Careers

Excellent opportunities have arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company. 

 

GW Pharmaceuticals was founded in 1998 and is listed on both the NASDAQ Global Market (GWPH) and AIM, a market of the London Stock Exchange. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes.

 

GW’s vision is to make a positive difference in the lives of patients through the development of a portfolio of cannabinoid prescription medicines in a wide range of therapeutic indications.  Our strategy is to build on our world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates.

 

Our lead product is Epidiolex, which is currently in Phase 3 FDA clinical trials being studied in a number of catastrophic childhood-onset epilepsy syndromes.  The product has been granted orphan drug status in those indications.  On 14 March 2016, we announced positive results from the Epidiolex Phase 3 trial in Dravet syndrome. 

 

GW has assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. GW maintains in-house control over all aspects of the cannabinoid product development process. GW also holds GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes

 

For details of GW’s current marketed product and international clinical research programme please refer to information on the company’s website: www.gwpharm.com.

To apply for an advertised position please send your CV together with a covering letter stating your salary expectations to recruitment@gwpharm.com.

 

Unfortunately we are currently unable to consider any speculative applications and so please do not apply for a position unless you believe yourself to be well suited to those advertised.

 

For all other recruitment enquiries please e-mail recruitment@gwpharm.com.

 

Due to the high volume of applications we receive if you do not hear from us within two weeks of applying then unfortunately you have not been successful on this occasion. We do thank you for your interest in working for GW and wish you every success with future applications.

Maintenance Technician

 

Permanent

South East, UK

 

 The Role

This expanding pharmaceutical company is looking for a Maintenance Engineer to join its Engineering Department based in South East England.

 The role is a key position within the company requiring mechanical maintenance skills appropriate to a pharmaceutical manufacturing and packaging environment.

 The successful candidate will provide Engineering services primarily in the form of mechanical and electrical systems maintenance together with other Engineering activities.  Quality is a primary focus to ensure that patients receive a safe, effective and quality assured product. This requires working to the principles of Good Manufacturing Practice (GMP). In order to achieve the high standards required, documented maintenance and calibration is an integral part of the daily routine.

You will be required to carry out mechanical maintenance tasks and to contribute to the efficient running of the Engineering Department.

 

Key Responsibilities

You will be required to carry out mechanical maintenance tasks and to contribute to the efficient running of the Engineering Department. Including:

 

  • Deliver maintenance tasks on time and to a high standard while maintaining compliance with equipment validation where applicable.
  • Carry out PPM tasks to a variety of equipment including bottle filling and packaging machines, API process equipment, AHU’s and utilities.
  • Complete documentation to GMP standards.
  • Work efficiently as part of a team.
  • As part of a team to prepare and perform Installation Qualification (IQ) and Operational Qualification (OQ) of new plant and equipment.
  • Provide technical support and Operator training where necessary.
  • Provide and keep up-to-date SOP’s for the Engineering Department.
  • Ensure that all equipment safety testing such as pressure/pressure relief is kept current and certified.
  • Supervision of contractors when required.
  • You will report to the Engineering Team Leader
  • The nature of the work requires team members to be flexible with regards to working time to ensure that they are available to support production processes should they overrun.

 

Essential Skills

A qualified Electro/Mechanical Engineer educated to C&G as a minimum with post qualification experience.  Some of this should have been gained in a regulated pharmaceutical production environment or similar industry.  As a minimum the jobholder should have worked under an ISO9000 quality environment and possess working knowledge of Microsoft Office applications.

 

Location: South East, UK 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Senior Medical Information Scientist

 

 Carlsbad, CA

 

About the role:

 

The Senior Medical Information Scientist will work as part of the Medical Information team and provide up-to-date, accurate and balanced information on products to internal and external customers. This role will a require an experienced Medical Information professional to undertake a key role in the Global Medical Affairs group to support both licensed and developmental products at this exciting time of growth for the company.

 

Responsibilities:

  • Generates standard and custom response materials.
  • Completes email and telephone enquiry logs
  • Responds to telephone calls and emails in a professional manner and ensures that medical enquiries are answered within the specified timelines
  • Produces monthly US MID report and liaises with UK MIO to relate to global report.
  • Delivers training to new GW employees and existing staff
  • Liaises with GW marketing partners
  • Executes additional tasks in order to meet departmental project-related or developmental/change objectives 

 

Requirements:

  • Doctorate level degree strongly preferred
  • Medical information pharmaceutical experience required
  • Competency with scientific/medical terminology; good IT skills; impeccable attention to detail; report writing experience and good  communication skills
  • Experience with Veeva, IRMS, or similar system, as well as MS Office.
  • Knowledge of medical information systems and pharmacovigilance and regulatory requirements.
  • Develops and maintains positive working relationships with others
  • DIA certification in Medical Communications
  • Strong and fluent communication skills, including ability to converse on lay-person level with compassion
  • AMCP dossier experience
  • Be comfortable working within a commercially-focused, fast-moving and delivery-orientated environment.
  • Medical Information/pharmaceutical experience preferred
  • Best practices Medical Information expert
  • Launch experience
  • Action oriented
  • Innovative 

To apply, please send your C.V, cover letter and salary expectations to usrecruitment@gwpharm.com

Senior Purchase Ledger Clerk

Permanent

 Andover, UK

 

Role

To assist in the day to day running of the Purchase Ledger

 

Duties

  • Authorise and approve invoices, including liaising with key staff in other departments, in time for payment run and month end deadlines
  • Assisting the purchase ledger team to ensure all invoices are on in a timely manner, suppliers are paid on time and statements are reconciled
  • Carry out the first review of payment runs
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Knowledge, Skills and Experience Required:

  • Prior Purchase Ledger experience
  • High level of numeracy
  • Communication skills both written and verbal
  • Excellent attention to detail
  • Proactive and positive attitude
  • Thorough and organised approach to working
  • A team player
  • The ability to develop and change with the business

 Knowledge, Skills and Experience Desirable:

  • A good working knowledge of Microsoft Excel
  • Knowledge of Sarbanes-Oxley compliant control environments would be advantageous
  • AAT qualified
  • Experience of Microsoft Navision accounting systems would be preferable.

 

This is a full time, permanent position.

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

Assistant Accountant

Permanent,

Andover, UK

 

Role

To assist with the completion of timely and accurate management accounts

 

Duties

  • Assist with the timely and accurate resolution of any issues
  • Completion of Monthly Accruals
  • Completion of the Contracts Review log
  • Weekly Bank Reconciliations
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job. 

Knowledge, Skills and Experience Required:

  • Prior Purchase Ledger experience
  • Prior Bank Reconciliation experience
  • High level of numeracy
  • Communication skills both written and verbal
  • Excellent attention to detail
  • Proactive and positive attitude
  • Thorough and organised approach to working
  • A team player
  • The ability to develop and change with the business 

Knowledge, Skills and Experience Desirable:

  • Previous Management Accounts experience
  • A good working knowledge of Microsoft Excel
  • Knowledge of Sarbanes-Oxley compliant control environments would be advantageous
  • AAT qualified
  • Experience of Microsoft Navision accounting systems would be preferable. 

This is a full time, permanent position.

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

Clinical Coordination Administrator - Cambridge, UK

 

6 month Fixed Term Contract

 

The Role

The role involves administration activities in support of the Clinical Coordination Department.

 

Key Responsibilities

  • Emergency Contact Administrator
  • Guideline Administrator
  • Template Administrator
  • Deputise for PRO Administrator
  • Deputise for Librarian
  • Deputise for Archiving Coordinator
  • Purchase order administration
  • Equipment administration
  • Administrative support to the Head of Clinical Coordination, and department managers.
  • Deputise for Office Manager/Office Administrator.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job. 

Essential Skills

  • Administrative experience in an office environment
  • Good working knowledge of Microsoft Outlook, Word and Excel.
  • Self-confidence and initiative.
  • Attention to detail.
  • Ability to prioritise and manage multiple & varied tasks.
  • Good interpersonal skills – including oral and written communication skills.

 Desirable Skills

  • Working knowledge of SharePoint
  • Administrative experience in a clinical research environment 

Location: Cambridge, UK

 To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com           

Associate Clinical Trial Administrator

Carlsbad, CA

 

About the role:

Provide administrative trial support of Clinical Operations objectives, contributing to the overall management of clinical trials in accordance with Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH) GCP and applicable local regulations. 

 

Responsibilities:

  • Provide support to Clinical Project Managers (CPMs) and Clinical Research Associates (CRAs) during the life of the clinical trial.
  • Coordination and tracking of clinical trials.
  • Set up and maintenance of paper and electronic trial filing systems.
  • Provide support to Clinical Coordination Department.
  • The job holder is responsible for maintaining current GxP (e.g. Good Clinical Practice (GCP)) and Health and Safety knowledge applicable to the job.
  • The Associate Clinical Trial Administrator is responsible for completing all required tasks delegated to Clinical Project Assistants (CPAs) in all GW SOPs and Guidelines.

 

Requirements:

Provide support to CPMs and CRAs:

  • Coordination of submissions/responses and tracking approvals and progress. May assist with maintaining and updating project related data in an existing database. i.e. CTMS, EDMS, which involves contacting internal team members to gather information.
  • Creates trial-specific binders as instructed; may coordinate the distribution of study materials, equipment and supplies (e.g. regulatory binders, ECG machines and syringes); assists the CRA with ensuring inventory is adequate at investigative sites.
  • Preparation of Clinical Trial Agreements and Financial Agreements in liaison with the Contracts Coordinator.
  • Preparation of site specific trial documentation, ensuring that accurate version control is applied.
  • Provide updates to trial documentation (as requested).
  • Attends CRA meetings, project team meetings and trial specific meetings and reports on trial progress as required, may assist with writing meeting minutes.
  • Coordination of project related mail merges.
  • Update Central Laboratories, Interactive Voice Response System (IVRS), Electronic Data Capture (EDC) and other service providers with site contact information (as requested).

Coordination and tracking of clinical projects:

  • Implementation and maintenance of logs, which may include the following; trial feasibility, trial tracking, monitoring visit reports and equipment.
  • Development and maintenance of trial progress logs to monitor subject recruitment and CRF monitoring.  Ensure log is updated throughout the working day so current recruitment figures are available.

Set up and Maintenance of Trial Filing systems:

  • Set-up and maintain Trial Master Files in accordance with company SOPs and ICH- GCP.
  • Ensure scanning/ uploading of US essential documents and electronic trial filing is completed.

Provide support to the Clinical Coordination Department:

  • Support team members as required, including acting as back-up if applicable.
  • Executes additional tasks in order to meet departmental project related or developmental/change objectives

 

Essential Skills and Education:

  • Self-confidence and initiative.
  • Excellent attention to detail.
  • Good interpersonal skills – including oral and written communication skills.
  • Basic time management skills
  • Able to work in a team and as an individual.
  • Working knowledge of MS Outlook, Word, Excel and PowerPoint.
  • High school/ secondary level education required. 

 

Desired Skills and Education:

Bachelor’s degree in life science or related field of study preferred or equivalent combination of studies, qualifications and/or work experience. 

 

Location: Carlsbad, CA

To apply please send your C.V and salary expectations to usrecruitment@gwpharm.com

Clinical Trial Administrator

 Carlsbad, CA

 

About the role:

Provide administrative trial support of Clinical Operations objectives, contributing to the overall management of clinical trials in accordance with Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH) GCP and applicable local regulations. 

 

Responsibilities:

  • Provide support to Clinical Project Managers (CPMs) and Clinical Research Associates (CRAs) during the life of the clinical trial.
  • Responsible for assisting sites and CRAs in review and collection of essential regulatory documents during study start-up, maintenance and close-down activities.
  • Coordination and tracking of clinical trials.
  • Set up and maintenance of paper and electronic trial filing systems.
  • Provide support to Clinical Coordination Department.
  • Assist in development of Clinical Coordination systems and procedures.
  • The job holder is responsible for maintaining current GxP (e.g. Good Clinical Practice (GCP)) and Health and Safety knowledge applicable to the job.
  • The Clinical Trial Administrator is responsible for completing all required tasks delegated to Clinical Project Assistants (CPAs) in all GW SOPs and Guidelines.

 

Requirements:

Provide support to CPMs and CRAs:

  • Coordination of submissions/responses and tracking approvals and progress. May assist with maintaining and updating project related data in an existing database. i.e. CTMS, EDMS, which involves contacting internal team members to gather information.
  • Creates trial-specific binders as instructed; may coordinate the distribution of study materials, equipment and supplies (e.g. regulatory binders, ECG machines and syringes); assists the CRA with ensuring inventory is adequate at investigative sites.
  • Preparation of Clinical Trial Agreements and Financial Agreements in liaison with the Contracts Coordinator.
  • Preparation of site specific trial documentation, ensuring that accurate version control is applied.
  • Provide updates to trial documentation (as requested).
  • Attends CRA meetings, project team meetings and trial specific meetings and reports on trial progress as required. May assist with writing meeting minutes.
  • Coordination of project related mail merges.
  • Update Central Laboratories, Interactive Voice Response System (IVRS), Electronic Data Capture (EDC) and other service providers with site contact information (as requested).
  • May assist in the planning and implementation of Investigator Meetings.
  • Provide training on relevant company processes.

Review of Essential Regulatory Documents:

  • Prepares initial essential document packages for distribution to sites in preparation for Investigational Product Shipment Authorization (IPSA) and site initiation.  Collects and reviews essential documents received from clinical sites to ensure all required documents are obtained, complete and in compliance with SOPs, GCP, and local regulations.
  • May assist with the preparation, review and submission of all relevant essential documents to Central IRB.  Provides support to sites/ CRAs for submission to Local IRB.
  • Reviews essential documents collected by CRAs during trial maintenance and close-down.  Provides feedback regarding any errors or inconsistencies with essential documents.
  • Assists with the translation of study documents required by investigative sites.

Coordination and tracking of clinical projects:

  • Implementation and maintenance of logs, which may include the following; trial feasibility, trial tracking, monitoring visit reports and equipment.
  • Development and maintenance of trial progress logs to monitor subject recruitment and CRF monitoring. 
  • Ensure log is updated throughout the working day so current recruitment figures are available.

Set up and Maintenance of Trial Filing systems:

  • Set-up and maintain Trial Master Files in accordance with company SOPs and ICH- GCP.
  • Ensure scanning/ uploading of US essential documents and electronic trial filing is completed.

Provide support to the Clinical Coordination Department:

  • Support team members as required, including acting as back-up if applicable.
  • Executes additional tasks in order to meet departmental project related or developmental/change objectives

Assist development of Clinical Coordination systems and procedures:

  • Write and review Clinical Coordination SOPs as required.
  • Write task specific guidelines/templates where appropriate.

 

Essential Skills and Education:

  • Self-confidence and initiative.
  • Excellent attention to detail.
  • Good interpersonal skills – including oral and written communication skills.
  • Basic project management skills
  • Able to work in a team and as an individual.
  • Knowledge of relevant regulatory guidelines and legislation.
  • Working knowledge of MS Outlook, Word, Excel and PowerPoint.
  • Previous clinical research or pharmaceutical industry experience.

Desired Skills and Education:

  • Bachelor’s degree in life science or related field of study preferred or equivalent combination of studies, qualifications and/or work experience. 

 

Location: Carlsbad, CA

To apply please send your C.V and salary expectations to usrecruitment@gwpharm.com

Management Accountant

South East, UK

 

6 month FTC

 

The Role

To aid with the accurate and timely completion of the monthly management accounts

 

Key Responsibilities

  • Monthly Stock Accounting including CoS and Variance Analysis
  • Fixed Asset Accounting
  • Various Month End Journals
  • Nominal Variance Analysis review and investigation
  • Various Balance sheet reconciliations
  • Preparation of Monthly Management Information Reports
  • Assist with Reforecasting/Budgeting              
  • Approval of Purchase Invoices
  • Liaise with Auditors at Quarterly Audits
  • To comply with all relevant SOX controls
  • Any other adhoc duties

 

Essential Skills & Experience

Knowledge:

  • Prior Stock Accounting experience preferably in a Manufacturing environment
  • Prior Management Accounts experience is essential

Skills:

  • A high-level working knowledge of Excel
  • High level of numeracy
  • Communication skills both written and verbal
  • Excellent attention to details

Attributes and Behaviours:

  • Proactive and positive attitude
  • Attention to detail, thorough and organised approach to working;
  • A team player;
  • The ability to develop and change with the business

Desirable Skills & Experience

  • Knowledge of Sarbanes-Oxley compliant control environments would be advantageous;
  • Working towards a AAT qualification or similar qualification
  • Experience of Microsoft Navision accounting systems would be preferable. 

Location: South East, UK

To apply, please send your C.V, cover letter and salary expectations to recruitment@gwpharm.com

Safety Surveillance Manager

 

Cambridge, UK

 

The Role             

The role holder is responsible for the management of safety surveillance activities for GW’s human medicinal products in both the pre- & post marketing setting.

 

Key Responsibilities

  • Support the QPPV for safety surveillance and signalling
  • Actively manage and run the safety surveillance meetings
  • Organising and scheduling Pharmacovigilance analysis of data
  • Undertaking data analysis and writing of safety reports
  • Line management
  • Database searches
  • Analysis of similar events
  • Issue work-ups
  • Information requests and responses
  • Actively maintain product core safety information 
  • Maintaining a strong GPVP & GCP knowledge.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job

 

Essential Skills & Experience

Knowledge:

  • Full understanding of clinical trials and the drug development process.
  • Life sciences degree with a sound clinical knowledge in diverse therapeutic areas
  • Strong background in drug safety / pharmacovigilance and safety signal analysis
  • Thorough knowledge of safety regulations and legal requirements
  • Extensive pharmaceutical safety experience.
  • Report writing and benefit risk analysis (pre- & post marketing) including aggregate report writing and issue work-up reports
  • Analysing safety data and writing responses to safety questions

Skills:

  • An experienced manager
  • Proficiency in safety databases and medical coding
  • Excellent communication skills including the ability to work with people at all levels.
  • Excellent organisational and time management skills.
  • Ability to be proactive, work on own initiative as well as part of a team.
  • Good attention to detail.

Attributes and Behaviours:

  • Have the ability of prioritising, planning and organising workload.
  • Maintain a positive working environment within the office
  • Demonstrate a “can do” approach.
  • Demonstrate highest level of confidentiality and discretion
  • Willingness to travel if required.

 

Desirable Skills & Experience

  • Experience of risk management activities & preparing Risk Management Plans

 

Location: Cambridge, UK

To apply, please send your C.V, cover letter and salary expectations to recruitment@gwpharm.com

Reports and Submissions Manager – Pharmacovigilance

 

Cambridge, UK

 

The Role

Responsible for the management of Pharmacovigilance reports and submissions for GW’s human medicinal products in both the pre- & post-marketing setting the role holder will be a dedicated manager who will actively run the reporting system in the department, with a focus on maintaining compliant and current core safety documents, plan all updates and carry out all submissions within the legal timelines.  The post holder will lead the communication of safety information into other operational functions.

Key Responsibilities

  • Support the QPPV, escalating safety and non-compliance issues
  • Actively maintain product core safety information 
  • Actively manage the safety report scheduling, resources and timelines.
  • Track and maintain compliance with regulatory timelines and submission requirements.
  • Work closely with the safety surveillance and case processing teams to achieve submission timelines
  • Manages new safety information resulting in updates to the core safety documents in a timely manner.
  • Organising and scheduling cross-functional meetings to communicate core safety changes.
  • Line management
  • Database searches and running reports
  • Responsible for organizing and tracking safety information requests and responses
  • Maintaining a strong GPVP & GCP knowledge.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job

 

Essential Skills & Experience

Knowledge:

  • Full understanding of clinical trials and the drug development process.
  • Life sciences degree with a sound clinical knowledge in diverse therapeutic areas
  • Strong background in drug safety / pharmacovigilance and document management
  • Thorough knowledge of safety regulations and legal requirements
  • Extensive pharmaceutical safety experience.
  • Experience of case management and safety report submissions, metrics.

Skills:

  • An experienced manager
  • Proficiency in safety databases, producing submissions metrics and medical coding
  • Excellent communication skills including the ability to work with people at all levels.
  • Excellent organisational and time management skills.
  • Ability to be proactive, work on own initiative as well as part of a team.
  • Good attention to detail.

Attributes and Behaviours:

  • Have the ability of prioritising, planning and organising workload.
  • Maintain a positive working environment within the office
  • Demonstrate a “can do” approach.
  • Demonstrate highest level of confidentiality and discretion
  • Willingness to travel if required.

Desirable Skills & Experience

  • Management in a drug safety/Pharmacovigilance environment.

 

Location: Cambridge, UK

To apply, please send your C.V, cover letter and salary expectations to recruitment@gwpharm.com

Clinical Trial Contract & Budget Manager

Carlsbad, CA

 

About the Role:

GW is looking for a Clinical Contract & Budget Manager to partner closely with finance and our clinical operations team to manage all contracts, budgets and payments for our clinical trials.  The Clinical Contract & Budget Manager will be responsible for full contract lifecycle management supporting clinical development (clinical operations, clinical sciences, and other assigned groups). In this position, you will be responsible for managing the cradle-to-grave contracting process of vendor contracts, including; reviewing contracts for adherence to stated terms and conditions, updating the contracts database, gathering signatures, distribution/archiving. Additionally, this person will support the development of key KPI/ROI metrics used as a reporting mechanism for management oversight

 

Responsibilities:

  • Management and contract negotiation for US clinical trials including vendor and research agreements
  • Key liaison with sites and other clinical vendors regarding contracts, payments and budgets
  • Determines appropriate budgets for clinical studies based on historical pricing, benchmarking, industry standards, etc.
  • Pricing and cost analysis, including assessment of Fair Market Values
  • Manages all aspects of a clinical trial agreement (CTA) from negotiation to signing through completion of agreement, utilizing a standard CTA and involving legal on an as needed basis
  • Prepares detailed budget to actual analysis: track and report on the progress of contract activities, providing regular status updates to stakeholders, analyze and develop an in-depth understanding of complex multi-million dollar budgets and be able to report to stakeholders on KPIs
  • Prepares clinical trial forecasts for new clinical trials, including market analysis, NPV as well as the cost of the clinical trial on a per patient basis
  • Ensures all payments to sites and/or vendors are appropriately approved, within budget and are made in a timely manner
  • Collaborates with worldwide clinical trial teams, investigational sites and vendors to verify and develop budget and negotiate cost savings
  • Works closely with clinical operations teams to ensure delivery of fully executed contracts in support of timely study start-up to meet departmental and organizational goals
  • Other duties as assigned
  • Some travel may be required

 Requirements:

  • Extensive knowledge of clinical research Phase II-IV
  • Experience leading the negotiation process for clinical trial sites, clinical service providers, labs and other external service providers
  • Bachelor’s Degree in finance or related field; CPA preferred but not required
  • Excellent negotiation skills and vast knowledge of clinical trial agreements
  • Strong financial background with experience and familiarity with clinical trials
  • Strong negotiation skills and vendor management experience
  • Proactive, innovative and problem solving skills
  • Excellent time management skills
  • Able to operate effectively in a fast-moving dynamic environment
  • Detail oriented 

Location: Carlsbad, CA

To apply for this position, please send your C.V and salary expectations to usrecruitment@gwpharm.com

Plant Breeder – South East, UK

 

Permanent

 

The Role

Be innovative in the use of plant breeding techniques to introduce new chemotypes, thereby broadening GW’s potential pipeline, and produce new genotypes to broaden GW’s collection and improve agronomic performance.

Along with the Assistant Plant Breeder, manage all practical aspects of the Plant Breeding.

 

Key Responsibilities

  • Optimisation and adjustment of plant materials of existing chemotypes.
  • Breeding of materials with novel chemotypes.
  • Performing research to increase understanding of genetic mechanisms that determine chemotype.
  • Reporting on progress internally and in the form of publications.
  • Setting up and monitoring projects and trials both in the glasshouse and in the field.
  • Collecting, preparing and analysing samples.
  • Recording and assessing data.
  • Maintaining breeding plant log to Home Office requirements.
  • Co-authoring scientific papers. 

Essential Skills

Knowledge:

  • Conventional plant breeding techniques,
  • Molecular biology techniques,
  • Plant secondary metabolites
  • Plant physiology. 

Skills:

  • Use of Gas Chromatography
  • Working knowledge of Excel
  • Written and verbal presentation skills
  • Excellent numeracy skills

 Attributes and Behaviours:

  • Innovative
  • Excellent attention to detail
  • Able to work in a team 

Desirable

  • Life Sciences degree

 

Location: South East, UK 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

IT Compliance Specialist – Cambridge, UK

 

6 Month Fixed Term Contract/Contract

 

The Role

To provide qualification and compliance support for IT infrastructure projects. The role holder will work as part of a team responsible for the generation and execution of IT infrastructure qualification documentation of to enable conformance with associated regulations (e.g. GxP, US FDA 21 CFR Part 11 and SOX).

 

Key Responsibilities

  • Support the development and implementation of IT compliance procedures for the management of a compliant, qualified infrastructure.
  • Perform qualification of IT infrastructure elements and projects in collaboration with the technical IT team.
  • Provide compliance documentation authoring support.
  • Provide IT compliance support for SOX projects.
  • Provide compliance support for technology and business projects such as software roll-outs, process improvements and managed changes.
  • Determine proper installation parameters for software and hardware to ensure compliant implementation.
  • Responsible for maintaining cGxP and H&S knowledge applicable to the job.
  • To ensure activities under own control are carried out in ways to minimise risks to health, safety, security and the environment.

 

Essential Skills & Experience

Knowledge and Experience

  • Experience working in an IT compliance or computer system validation (CSV) role within a Pharmaceutical or ISO environment
  • Experience of writing and executing IT infrastructure qualification documentation
  • Experience of Microsoft Windows Operating Systems, productivity tools and networked environments.
  • Good experience of the software development lifecycle
  • Excellent attention to detail and ability to produce high quality documentation
  • Ability to interact confidently and effectively across a range of disciplines
  • Excellent analytical and problem solving skills
  • Good prioritisation skills and flexibility to adapt to changing priorities
  • Ability to work to tight deadlines
  • Self-starter with the ability to use initiative and work without supervision
  • Possesses strong verbal and written, interpersonal and organisational skills
  • Develops and maintains positive working relationships with others
  • Shares ideas and information
  • Assists colleagues as and when required and demonstrates a ‘can do’ approach

Desirable Skills and Experience

  • Knowledge and understanding of GxP, GAMP5, 21 CFR Part 11 and SOX
  • Experience of working with IT contractors, developers and suppliers

Location: Cambridge, UK 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Principal Medical Writer

RTP - Remote

 

About the Role:

In this role, the Principal Medical Writer will complete medical writing activities to appropriate quality standards and required timelines, mentor the junior team members and deliver training, as required and project management activities on behalf of the Clinical Operations Department.

 

Responsibilities:

  • Identifies leads for potential consultants and CROs for outsourced medical writing activities, assisting with the set-up of contracts and document exchange, and maintenance of good working relationships.
  • Writing, formatting, review or QC checking of the following essential documents;

Clinical study reports.

Clinical study protocols

Investigator Brochures

Investigational New Drug (IND) application and annual updates.

Manuscripts for submission to peer-review journals, conference abstracts, posters and presentations.

Documents contained in the modules of the Common Technical Document (CTD).

GW guidelines and templates.

  • Conducts literature reviews and summarizes relevant information.
  • Writes, prepares and/or QC checks other clinical documentation, as applicable.
  • Writes GW SOPs and Guidelines, and updates related documents, as required.
  • Ensures relevant clinical trial information is uploaded onto ClinicalTrials.gov and EudraCT in accordance with regulatory requirements and GW SOPs.
  • Is responsible for ensuring up-to-date with company SOPs, relevant regulations and legislation and to ensure that company documentation meets with these standard. s.
  • Carries out their work in a way that will not adversely affect their own, or others’, health, safety and security or the environment and reports any shortcomings in GW arrangements.
  • Identify additional training needs of the medical writing team and liaise with line manager to implement training.
  • Undertakes review of essential trial-related documents, assisting the Clinical Team, as required.
  • Other duties as assigned.
  • Some travel may be required. 

Requirements:

  • Scientific graduate; PhD in Biomedical Sciences desirable.
  • Good knowledge of relevant regulations and legislation.
  • Good knowledge of company SOPs.
  • Excellent written English with ability to interpret data and express findings in a clear and concise manner.
  • Excellent attention to detail.
  • Excellent organizational and time management skills.
  • Excellent communication skills including ability to work with colleagues across all clinical development functions.
  • Comprehensive computer skills, particularly in the use of Microsoft packages.
  • High level of numeracy.
  • Ability to be proactive, to work on own initiative and as part of a team.
  • Flexibility in meeting challenging deadlines and changing requirements.
  • Develops and maintains positive working relationships with others. 

Location: USA

To apply for this position, please send your C.V and salary expectations to usrecruitment@gwpharm.com

Manager/Senior Manager of Regulatory Affairs

Carlsbad, CA

 

 About the Role:

 

To write, submit, and maintain labeling for US applications (INDs and NDAs) according to ICH and FDA regulations

 

Responsibilities:

  • Plans, coordinates and participates in writing, preparation, assembly, and maintenance of labeling for US applications to regulatory authorities
  • Creates and manages labeling timelines and provides operational guidance and regulatory advice to submission teams
  • Builds and maintains relationships with other functions within GW
  • Maintains Regulatory Systems and provides administrative support
  • Other duties as required
  • Identifies or is made aware of the need for a new or revised label to support one of the US applications.  Works with key stakeholders to develop timelines and content for the label. 
  • Coordinates contributions to, annotations of, and the quality control review for US labeling documents
  • Compiles the labeling and supporting documentation and oversees that the submission is appropriately reviewed and approved
  • Creates and maintains appropriate tracking tools and files
  • Participates in or leads conference calls and meetings on US labeling activities
  • Provides labeling guidance to other stakeholders
  • Leads conference calls for labeling strategy topics and projects
  • Liaises with all necessary colleagues to keep them informed of progress, actions, and activities, as necessary
  • Acts on behalf of other US Regulatory Affairs colleagues when requested
  • Proactively keeps manager informed about work progress and any issues (including conflicting priorities and free capacity)
  • Maintain a working knowledge of and ensure compliance with applicable ICH Guidelines, US regulations, GW Pharmaceuticals’ SOPs, other GW training requirements, and study specific procedures and training
  • Escalate any issues that require immediate action to Head of US Regulatory Affairs
  • Carry out work in a way that will not adversely affect their own or others’ health, safety, and security or the environment and reports any shortcomings in GW arrangements.
  • Other duties as assigned
  • Some travel will be required 

Requirements:

  • Bachelor of Arts/Science degree in a relevant discipline
  • Labeling, regulatory strategy, and project management experience
  • Experience and interactions with FDA on labeling, including organizing and leading meetings with FDA
  • Shares ideas and information, seeks out collaboration and advice as needed
  • Knowledge of FDA and ICH guidelines
  • Organizational and time management skills
  • Self-starter and problem solver
  • Able to work in a team and contribute as an individual
  • Good communication skills and customer service oriented
  • Excellent attention to detail
  • Adaptable and flexible

 Location: Carlsbad, US

To apply, please send your C.V and salary expectations to usrecruitment@gwpharm.com

Pharmacovigilance Physician –Cambridge, UK

 

Permanent

 

Job summary:

To provide medical input into the global Pharmacovigilance department and activities with the objective of ensuring medical integrity.

 

Responsibilities include:

  • Support the QPPV for medical safety matters
  • Medical evaluation of individual case reports, including causality assessment and MedDRA coding
  • Signal detection
  • Medical advisory role
  • Risk management activities
  • Report writing and benefit risk analysis (pre- & post marketing)
  • Preparing Risk Management Plans
  • Responses to safety questions
  • Aggregate report medical review
  • Maintaining a strong GPVP & GCP knowledge.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job 

Qualifications/ Experience required:

Knowledge:

  • Full understanding of drug development process.
  • Medical degree with a sound clinical knowledge in diverse therapeutic areas: must be registered with the General Medical Council.
  • Strong background in drug safety / pharmacovigilance
  • Thorough knowledge of safety regulations and legal requirements

Skills:

  • Excellent communication skills including the ability to work with people at all levels.
  • Excellent organisational and time management skills.
  • Ability to be proactive, work on own initiative as well as part of a team.
  • Computer literate and competent in the use of Pharmacovigilance databases
  • Good attention to detail.

Attributes and Behaviours:

  • Have the ability of prioritising, planning and organising workload.
  • Maintain a positive working environment within the office
  • Demonstrate a “can do” approach.
  • Demonstrate highest level of confidentiality and discretion
  • Willingness to travel if required.

 Desirable Qualifications/Experience: 

  • Extensive pharmaceutical experience in safety or clinical development
  • Should either have or be prepared to take the Diploma in Pharmaceutical Medicine or equivalent qualification. 

Location: Cambridge, UK

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com               

Financial Controls Manager

 

Cambridge or Andover - UK

 

Job summary:

The job holder will be primarily responsible for leading improvements to the Group’s Sarbanes Oxley (“SOX”) compliance.

 

Responsibilities include:

  • Liaise with the Chief Financial Officer and the Audit Committee to assist the business with SOX compliance and to ensure all elements are executed to plan.
  • Identify and lead improvements to the Group’s SOX documentation and approach.
  • Be responsible for, planning, managing and executing a rolling programme of SOX testing, managing resources appropriately.
  • Liaise with key internal stakeholders in finance to identify potential weaknesses.
  • Review and manage all documentation produced in scope locations, ensuring consistent quality across the Group.
  • Develop new controls and processes for areas of expansion for the Group, predominantly for US operations.
  • Liaise with the external auditors to ensure that their testing of the Group’s SOX environment is both timely and relevant to each SOX cycle.

 

Qualifications/ Experience required:

Knowledge:

  • Knowledge of SOX, IFRS, SEC, PCAOB and COSO
  • Progressive SOX experience in a public accounting firm and/or private industry SOX compliance department
  • Experience in a US publicly traded company
  • Chartered/certified accountant or similar internal audit qualification
  • Confidence, good judgment, energy and personality to work in a dynamic environment across all levels of management and across business units and functions. Must be able to drive change in a fast-moving environment and work effectively across the organization
  • Project management experience is essential 

Skills:

  • Strong communication skills, both written and verbal;
  • Ability to liaise with senior members of business and suggest appropriate improvements to business processes; and
  • Excellent attention to detail.

Location: Cambridge or Andover, UK

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

BDS Process Technician – Permanent

 

South East, UK

 

The Role

The BDS Process Technician is responsible for processing Botanical Drug Substance (BDS) using a series of well-defined and documented manufacturing processes/procedures. Whilst being in compliance with Health and Safety (H&S) and current Good Manufacturing Practices (cGMP) requirements.

 

Key Responsibilities

  • Process manufacture of BDS.
  • Recording of manufacturing/process conditions in batch documentation and equipment/area logbooks.
  • Complete area/equipment cleaning procedures to high standards as illustrated in cGMP practices.
  • Authoring and reviewing of batch documentation and Standard Operating Procedures (SOP).
  • Completing additional tasks assigned by Production management that are outside the core duties described above.

 Essential Skills

  • Experience gained in a regulated production environment, ideally within the pharmaceutical/chemical or food industry.
  • Good level of numeracy.
  • Good communication skills including written.
  • A good working knowledge of standard Microsoft packages, i.e. Excel and Word.
  • The ability to work on own or in a small team environment.
  • Excellent attention to detail.

 Desirable

  • Ideally hold qualifications gained in the Pharmaceutical industry i.e. NVQ’s, or similar. 

 

Location: South East, UK

To apply please send your CV with salary expectations to recruitment@gwpharm.com

QC Scientist

 

South East, UK

 

The Role

Reporting to the QC Team Leader, the QC Scientist will be involved in multiple areas of QC testing (raw material, API, finished product, stability) as well as various laboratory support activities (method validation, instrument calibration and qualification). 

 

Key Responsibilities

  • Validation of analytical methods and qualification of laboratory instruments
  • Perform routine analytical testing using GC, HPLC, TLC, FTIR and other required techniques in accordance with written procedures
  • Provide clear and accurate records of all work performed
  • Ensure all analytical operations are performed in accordance with cGMP regulations
  • Creating and updating documents in accordance with cGMP and company procedures

 

Essential Skills

  • Educated to degree level in chemistry (or related science based subject) as a minimum
  • Hands on experience of working in a “small molecule” pharmaceutical or other regulated laboratory within a professional environment
  • High level of knowledge and understanding of cGMP regulations
  • Experience in analytical method validation and instrument qualification
  • Knowledge and understanding of data integrity requirements
  • Knowledge and experience of QC analytical testing and the use, and troubleshooting of, analytical instrumentation
  • Good communication, presentation, coaching/training, and team working skills
  • Computer literate
  • High level of numeracy
  • Excellent attention to detail and ‘concern for quality’
  • Develops and maintains positive working relationships with others
  • Demonstrates a ‘can do’ approach

Desirable:

  • Experience of using the Empower CDS
  • Knowledge of CSV requirements in a GMP environment
  • Knowledge of stability testing and associated guidelines
  • Experience of Pharmacopoeial testing and the use of Pharmacopoeias

 

Location: South East, UK

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Medical Director

Carlsbad, CA

About the Role:

 

  • Develop strategies for the clinical development program and designs the trials in cooperation with key opinion leaders to advance products.  
  • Implement, monitors, and evaluate all clinical trials in the clinical development programs.
  • Lead study teams in interpreting trial results and in constructing the study reports.
  • Work with Medical Affairs to produce timely publications written with external opinion leaders.
  • Present scientific data from the clinical program at professional meetings and meetings with authorities as well as internal meetings.
  • Take responsibility to ensure all reports and literature from the clinical program are scientifically sound and accurate and will identify issues that require further study and/or expert evaluation. 
  • Work closely with internal cross-functional stakeholders, external investigators, various corporate partners and regulatory authorities.

 

Responsibilities:

  • Provides medical expertise on clinical drug development throughout life-cycle of compound:
  • Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material.
  • Provides continuous medical monitoring during study conduct, answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates  and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study.
  • Provides therapeutic training relevant to specific study to the project team.
  • Attends and/or presents at investigator, internal and external project team meetings.
  • Defines criteria for, assesses and evaluates protocol deviations and recommends on actions to be taken.
  • Makes decisions on medical issues that arise during clinical trials.
  • Assumes responsibility for ethical, e.g. medical, aspects of study.
  • Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients.
  • Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.
  • Assists the clinical team in selection and recruitment of investigational sites.
  • Develop clinical trial programs to support product registration and marketing.
  • Establish ongoing liaison with key opinion leaders, government officials, and healthcare organizations and ensure that significant developments in the field are identified and monitored.
  • Provide leadership and medical expertise in the development of clinical research strategic programs in line with global strategy and to support local product registration and marketing.
  • Provide medical and scientific input to global product development teams.
  • Provide medical expertise in the review of adverse experiences locally and contribute to global pharmacovigilance activities.
  • Supports generation of publications and expert reports:
  • Reviews and interprets study results and clinical study reports.
  • Generates expert reports and supports IAS/IAEs, NDAs/PLAs, and other regulatory submissions, as well as generates and/or reviews publications, posters, and scientific presentations.
  • Advises Medical Affairs in developing and implementing publication plans.
  • Presents clinical data represents GW Pharmaceuticals at professional meetings and meetings with authorities.
  • Represents Clinical Sciences at internal meetings.
  • Other duties as assigned.
  • Some travel may be required, primarily for medical meetings, site visits, and meetings with authorities.

 

Requirements:

  • Industry experience required with full understanding of safety, rules and regulations of industry, preferably with neurologic drugs.
  • Board certification required with a specialty in neurology and pediatrics preferred.
  • Active US Medical license required.
  • NDA experience preferred.
  • Excellent oral and written communication skills and experience with publications.
  • Ability to work collaboratively in a dynamic team-based environment.
  • Possess a basic understanding of applicable US and EU regulations, the drug development process, biostatistics and pharmacokinetics.

 

Location: Carlsbad, California

To apply please send your C.V and salary expectations to usrecruitment@gwpharm.com

Regulatory Affairs Manager – CMC

 

South East UK

12 Month FTC

 

Job summary:

The job holder manages the writing/drafting, compilation and review of dossier sections (IMPD, IND, NDA or MAA) based from source technical or quality reports, to support company clinical trials applications or applications for Commercial Licences. The role also involved the above activities for agency meeting briefing books (CMC) and responses to agency quality questions.

 

Responsibilities include:

  • To draft and organise functional review for the CMC sections of Marketing Authorisation Applications (MAAs) and New Drug Applications ( NDAs) and IMPDs/INDs
  • To revise documents in line with comments/critique.
  • To ensure QC to finalised CMC documents and acceptability to the head of the CMC RA group, before use in publication.
  • To have an awareness of GxP and in particular GMP compliance.
  • To manage work in order to meet the agreed submission schedules.

 

Qualifications/ Experience required:

Knowledge:

  • Degree level education in Life Sciences.

Experience:

  • Experience of working in CMC Regulatory Affairs in the Pharmaceutical industry
  • Practical experience of CMC dossier sections.
  • Experience of CMC regulatory submissions, receipt of questions from competent authorities.

Skills:

  • Good working knowledge of ICH regulatory requirements.
  • Understanding of the inter-relationships between Quality, Safety and Efficacy aspects of MAAs, INDs and IMPDs.
  • Communication skills including written and presentational.
  • IT competency.
  • Develops and maintains positive working relationships with others.
  • Regulatory CMC document writing skills.
  • Proven organisational skills, particularly when time constrained.
  • Self-motivate approach, with a willingness to assist colleagues to achieve goals 

Desirable

  • US Submissions.   

Location: South East, UK

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

Legal Counsel

 

Cambridge or London, UK

 

Job summary:

The job holder is primarily responsible for the day-to-day activity of structuring, drafting and negotiating commercial contracts with GW’s key vendors and service providers. The job holder is also responsible for assisting with maintaining commercial and corporate policies and procedures, and ensuring consistent application of these throughout the business, through partnering with the business.

 

Responsibilities include:

  • Providing legal advice to GW on a variety of legal matters and transactions, including commercial contracts, distribution agreements, collaboration and licensing arrangements, marketing/communications materials, product documentation, corporate transactions (e.g. M&A support).
  • Acting as a business partner by applying combined business and legal judgment to proposed deals, relationships, and other issues requiring legal attention, strategic commercial legal advice, and support of key initiatives
  • Drafting, reviewing, and negotiating business agreements and transactions
  • Supporting on dispute resolution and/or litigation and other matters, where appropriate
  • Supporting the development and implementation of legal affairs and compliance strategies for GW

 

Qualifications/ Experience required:

Education

  • Graduate and a solicitor or barrister.

 Knowledge and experience of:

Essential

  • Business law experience at a top law firm or corporate legal department, including but not limited to drafting, negotiating and closing business transactions
  • Previous experience drafting and negotiating complex business transactions
  • Previous experience prioritising conflicting demands from multiple business clients in an extremely fast-paced environment 

Knowledge and experience of one or more of the following areas:

  • Company secretarial and corporate governance practices and policies
  • Health care regulations, guidelines and voluntary codes of practice - particularly with regard to clinical trials regulations, product approvals, and advertising and marketing
  • Data privacy
  • Claims and disputes and general commercial litigation
  • Competition and anti-trust laws
  • UK property transactions  

Location: Cambridge or London, UK

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

Medical Science Liaison

 

Various Locations Available

 

About the role:

 

The Medical Science Liaison (MSL) is a member of a field-based team of scientists who function as an extension of the US Medical Affairs organization. MSLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development. MSLs provide medical information through scientific exchange, and clinical/scientific support for GW Pharmaceuticals and the Medical Affairs department.

This is a field-based position and requires professionals with established personal and scientific credibility to interact with thought leaders and academic centers of excellence.

 

Responsibilities:

  • KOL Development and Field Engagement:
  • Identify and develop peer-to-peer relations with key opinion leaders (KOLs) and healthcare providers within neurology & epilepsy therapeutic areas
  • Develop and execute territory plans in alignment with regional and national Medical Affairs plans
  • Collaborate across multiple functions to maximize territory opportunities
  • Identify and communicate key clinical and research issues and insights from KOLs to appropriate departments
  • Participate in medical education for healthcare professionals (HCPs) through on-site presentations at healthcare institutions, investigator meetings, national conferences, advisory boards, or regional meetings
  • Provide scientific and clinical support on GW Pharmaceutical products to formulary committees or payers in collaboration with market access
  • Provide scientific support for additional activities such as medical congress staffing, advisory boards, and sales training initiatives

 

Medical Information Management:

  • Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic, community, and healthcare provider settings in both group and one-on-one situations
  • Serve as medical consultant to internal medical information department to assure the development of quality standard response letters

 

Clinical Development and Pipeline Management:

  • Act as primary liaison to investigators interested in performing investigator initiated trials (IIT)
  • Monitor investigator-initiated research, review study design, and oversee milestone requirements to ensure progression of investigator- or company-sponsored clinical research
  • Collaborate with medical affairs and clinical organization to support patient enrollment in GW Pharmaceutical -sponsored clinical trials with site recommendations
  • Serve (as needed) as internal scientific advisor in the evaluation of new products and technologies under consideration for portfolio enhancement/expansion

 

Requirements:

  • MS degree in scientific and/or medical discipline is required; MD, PharmD, or PhD is strongly preferred
  • MSL experience in Epilepsy is strongly preferred
  • Experience as a Medical Science Liaison is required
  • Demonstrated ability to partner and maintain relationships within the medical community
  • Excellent presentation and teaching skills with a strong scientific and pharmaceutical knowledge required
  • Clinical or research experience in Epilepsy/Neurology preferred
  • Current working knowledge of US legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals is preferred
  • Strong capabilities working with digital platforms and tools is required
  • This is a field position and applicants must be willing to travel 60-80% time

Applicants must have a valid driver’s license and live within 30 miles of a major airport

 

Location: Various, US

To apply please send your C.V and salary expectations to usrecruitment@gwpharm.com

Automation Engineer

Permanent, South East UK

 

Role

  • To lead and take ownership of all the manufacturing automation and control systems on site.
  • To support the automation and control systems through their lifecycle (development of URs and FDs, through to installation, commissioning, qualification, validation and system maintenance).

Duties

  • To develop and support automated systems to ensure systems are operational and appropriate for use by production. Systems to include all Process Control Systems, Batch Historians, and Independent Monitoring System (IMS).
  • To provide technical knowledge on automation projects, plant modifications and continuous improvement projects.
  • To ensure that all manufacturing and related activities associated with automated control systems are performed in accordance with all relevant internal/external quality and safety standards.
  • Act as Subject Matter Expert (SME) to all external regulatory bodies, marketing partners and suppliers for all Production/manufacturing automated systems.
  • To develop short, medium and long term improvement plans for implementation within the automated systems.  Take responsibility for investigating and introducing new engineering technologies and strategies.
  • To develop the skills, and knowledge of production, engineering, technical staff and work teams on Automation and Control Systems by training and mentoring.
  • Facilitate interface between automated system and centralised ERP system.
  • Perform validation activities in collaboration with Computer Systems Validation (CSV) team

 

Knowledge, Skills and Experience Required:

  • A background in Automation and Control is essential.
  • Experience with PLC’s and SCADA control systems is a key requirement.
  • Will have a demonstrated track record with relevant experience working in a regulated industry preferably in Pharmaceuticals. Working in a cGMP or regulated industry would be preferable.
  • Knowledge of Rockwell Automation ControlLogix and FactoryTalk technology would be advantageous.
  • Qualification to degree or equivalent standard would be an advantage.
  • Project Management experience.
  • Direct involvement in regulatory audits (cGMP and EHS).
  • Able to form long term relationships with key support groups; QA, engineering, CSV group and senior managers across the site.
  • Interacts with other functions and sites regarding broader projects.
  • Good oral, written and presentation skills essential.

 

This is a full time, permanent position.

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

US Regional MSL Manager

 

Various locations accepted -- Large airport access required

 

About the role:

 

The Medical Science Liaison (MSL) Manager will lead a field-based MSL team, functioning as an extension of the US Medical Affairs organization. Working with Medical Affairs leadership, the MSL Manager will provide strategic and operational support for executing the MSL tactics as well as ongoing territory development. This position will involve oversight of key MSL programs regionally and nationally as necessary. The strategic areas of focus include scientific exchange, health-care decision maker education, and research. MSLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development, and the MSL Manager will be critical to successfully meeting these objectives at the individual and field-team levels.

 

Responsibilities:

  • Develop and execute field business plans based on the US Medical Affairs strategic plan
  • Hire and train MSL team members 
  • Structure and lead a team of MSLs to provide innovative and optimized medical leadership during a US product launch
  • Interpret and translate national strategies into MSL territory business plans that include development and engagement with regional opinion leaders. Opinion leader development includes appropriate engagement with disease experts in research, as speakers, as advisors and other disease related activities
  • Manage and develop a team of MSLs including hiring, field training, evaluation, motivation, and disciplinary activities in alignment with GW’s corporate strategies and objectives. Provide strong leadership to motivate MSLs and achieve excellent results that align with corporate goals and culture
  • Ensure that all interactions and activities in the region comply with GW business guidance, policies, and SOPs, FDA, and PhRMA guidelines/policies
  • Maintain relationships with a small list of national level opinion leaders within their region to enhance engagement for strategic initiatives
  • Guide and assist the MSLs in the coordination of opinion leader interactions across the region and with other external stakeholders as necessary
  • Develop and maintain productive and appropriate relationships with individuals across the organization to include commercial and clinical development
  • Appropriately partner with the commercial field team and corporate team to provide necessary and appropriate medical resources in the region and corresponding districts
  • Clearly communicate national, regional, and territory plans and tactics; define, clarify and manage MSL team priorities; actively support the MSL team within their scope of responsibility by being their advocate and spokesperson; promote collaboration within the team, across work groups and with customers
  • Collaborate within medical affairs to appropriately respond to unsolicited requests for pipeline or off-label information
  • Represent the MSL function on US medical affairs teams as necessary

Requirements:

  • Master’s level scientific education required. MD, DO, PharmD, or PhD strongly preferred
  • Relevant industry experience, people management experience is required; product launch experience highly desired
  • Experience building MSL business plans based on medical affairs strategy is required
  • Experience building an MSL team for a new organization is preferred
  • Field experience as an MSL is required
  • Experience and expertise in the field of epilepsy is preferred; Neurology therapeutic area experience is required
  • Excellent communication, presentation and time management skills are required; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization
  • Strong understanding of US legal, regulatory, and compliance regulations and guidelines is required
  • Strong capabilities working with digital platforms and tools are required
  • Ability to travel at least 50% of the time

Location: Various, US

To apply please send your C.V and salary expectations to usrecruitment@gwpharm.com

Senior Regulatory Affairs Specialist - Cambridge

 

Permanent

 

The Role

The Senior Regulatory Affairs Specialist will be involved in the preparation of Clinical Trial Applications, Marketing Authorisation Applications (MAAs), Paediatric Investigational Plans, Orphan Drug Applications and Scientific Advice procedures in Europe. The role holder will be responsible for regulatory maintenance activities.

 

Key Responsibilities

  • Prepares Marketing Authorisation Applications (MAAs) and ensures maintenance activities are successfully undertaken.
  • Prepares paediatric investigational plans, orphan drug applications and scientific advice documentation
  • Compiles and coordinates the submission of clinical trial applications
  • Responsible for Regulatory maintenance activities

 

Essential Skills

Knowledge:

  • Degree in life sciences.

Experience:

  • Planning of Regulatory maintenance activities
  • Preparation of MAAs, paediatric investigational plans, orphan drug applications and scientific advice procedures.
  • Preparation and submission of clinical trial applications
  • Proven experience in the commercial pharmaceutical environment. 

Skills:

  • Good organisational and prioritisation skills.
  • Good communication skills.
  • IT competency - Excel / Word / PowerPoint.
  • Excellent attention to detail.
  • Project Management.

 

Location: Cambridge, UK

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Horticultural Technician - South East UK

 

Permanent

 

Job summary:

We currently have a vacancy for a Horticultural technician to assist with our crop research, development and production facilities.

 

Responsibilities include:

Reporting to the Botanical Research Manager you will be part of the horticultural team involved with the propagation, maintenance, harvest and processing of research and commercial crops grown within the our facility. The successful candidate must work within a GxP environment and operate within the bounds of standard operating procedures.

Tasks required within the role will include:

  • Planting of seed
  • Preparation of cuttings
  • Planting of crops
  • Watering
  • Application of biological control
  • Crop monitoring
  • Harvesting of crops
  • Processing and packing
  • Documentation and audit
  • Weekend duties
  • Facility maintenance and cleaning as required 

Qualifications/ Experience required:

  • The ideal candidate will have a passion for horticulture and a good working knowledge of horticultural techniques.
  • Excellent attention to detail, an ability to develop positive working relationships with others and a demonstrable ‘can do’ approach will be required.
  • Horticultural qualifications would be desirable but not essential as training will be provided.
  • Experience of team working within a horticultural environment is expected.
  • Experience of quality control systems within the workplace would be beneficial although training will be provided.
  • Sound numerical and literacy skills are required due to the level of documentary work necessary.
  • Good computer literacy and a good working knowledge of Microsoft office would be beneficial.  

Working Hours           

  • Full time 40hpw.  Rotational weekend working (Up to one weekend per month) 

To apply for this position please send your CV with a covering letter and salary expectations to recruitment@gwpharm.com

Data Manager - 12 Month FTC

 

Cambridge

 

The Role

 

Responsible for planning, organization, leadership and coordination of all data management activities on assigned projects (Phase I to IV) right from the database set-up till project closure; and ensures quality and timely data management deliverables.

 

Key Responsibilities

  • Oversees project related data management activities for outsourced projects including but not limited to, CRF design, data collection, edit checks & offline listings review, external data reconciliation, Serious Adverse Event reconciliation, medical coding, quality control of database, database locks and archival of data management documents
  • Liaises with GW’s Safety Group and Data Management group to ensure Serious Adverse Events reconciliation is completed at agreed intervals.
  • Liaises with external vendors and Data Management group to facilitate Data Transfer Specifications are created/reviewed/approved and the transfer files are sent at agreed intervals.
  • Participates in project team meetings as primary Data Management representative, providing regular status updates and metrics to the cross functional team.
  • Manages timelines for assigned projects and ensure that all applicable Clinical Data Management staff are aware of GW’s deliverables.
  • Coordinate archiving activities to ensure CRF data and study documentation is appropriately archived
  • Responsible for performing all tasks in adherence to GCP guidelines and maintain H&S knowledge applicable to the job.

 

Essential Skills

Knowledge

  • Bachelors or Master’s Degree in Life Sciences
  • Demonstrate sound knowledge of Drug Development Process and Clinical Data Management processes.
  • Good Knowledge of ICH and GCP guidelines

Experience:

  • Experience in Clinical Data Management.
  • Experience with study start up and closeout

Skills:

  • Excellent verbal and written communications skills and ability to interact with personnel at all levels cross functionally
  • Ability to think critically and use good problem solving skills
  • Strong organisational and time management skills
  • Excellent attention to detail

Desirable Skills

  • Knowledge of SAS system and data standards e.g. SDTM

Location: Cambridge

To apply please send your C.V and salary expectations to recruitment@gwpharm.com

Senior Statistician - 12 Month FTC

 

Cambridge or Homebased

 

The Role

 

The Senior Statistician is a member of the clinical team and is responsible for statistical input, including SAS programming, to clinical studies.  The role holder is responsible for ensuring that activities and processes performed are conducted according to company requirements.  This position works closely with other team members.

For this role, experience in early phase (Phase I/II) with excellent understanding of PK and the statistical reporting/analysis of early phase/PK studies is essential.

 

Key Responsibilities

  • Act as Representative Statistician on study teams, so as to provide timely input.
  • Statistical input from inception through to reporting of Phase I, II and III studies, ensuring high scientific standards for all studies.
  • Perform statistical analyses of data and interpret results, ensuring validity of conclusions.
  • Respond to regulatory questions regarding submissions
  • Prepare and coordinate for blinded data review meetings prior to database lock.
  • Perform ad hoc review of data and analyses following unblinding, as required.
  • Ensure that appropriate programs are developed for reporting clinical studies (if applicable).
  • Perform statistical quality control review and program validation for studies (if applicable).
  • Work and ensure adherence to CDISC standards for applicable clinical trial reporting.
  • Respond to regulatory questions regarding submissions.
  • Carries out their work in a way that will not adversely affect their own, or others’, health, safety and security or the environment and reports any shortcomings in GW arrangements.

 

Essential Skills

  • Master’s degree in Statistics or a subject with a major statistical component with relevant experience (production of statistical analysis plans and statistical reporting/generating TFLs are essential for this role).
  • Good knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
  • Proficient in the use of computers and especially the SAS system.
  • Ability to perform and interpret statistical analyses of clinical data.
  • Have a good understanding of clinical data, including data quality issues.
  • Able to work in a fast-paced, team-oriented environment.
  • Possess excellent interpersonal and communication skills (written and verbal).
  • Strong attention to detail with a view to bringing studies to a quality conclusion.
  • Flexible, positive, creative thinker, good communicator.
  • Able to work without close supervision.
  • Well-developed time management skills.

Desirable

Previous management/leadership experience.

 

Location: Cambridge or Homebased

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Senior SAS Programmer - 12 Month FTC

 

Cambridge or Homebased

 

The Role

The Senior SAS programmer is responsible for SAS programming on clinical studies and will support the Data Management (if required) and Statistical reporting for clinical studies.

 

Key Responsibilities

  • Act as a Study Programmer on study teams, managing your time so as to provide timely input.
  • SAS programming to support the statistical reporting, including production of listing, tables and figures, for Phase II to IV clinical studies and Pharmacovigilance data.
  • Review and monitor data received from data management to ensure suitability for reporting.
  • Assist in design of study databases (in SAS datasets) ensuring adherence to CDISC standards (when required) whilst creating databases that are amenable to processing within the Biometrics department either individually or as integrated summaries.
  • Programming of ad hoc queries on study databases.
  • Act as a principal SAS programming contact within GW.
  • Perform quality control review of work completed by other members of the team or CROs.
  • Interact with report writers in the production of integrated clinical reports and other documents containing information from clinical study databases.
  • Interact with other disciplines to ensure successful execution of studies.
  • Input into the development of departmental processes, including standard working practices, operating procedures and implementation of CDISC.

 

Essential Skills

  • Bachelor’s degree preferred with of relevant experience.
  • Thorough knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
  • Proficient in the use of computers and especially the Windows operating system and Microsoft products.
  • Proficient in the use of the SAS system, especially SAS Base; experience of the use of SAS/Graph and SAS/Stat would be an advantage.
  • Familiar with data from clinical trials.
  • Training in statistics would be an advantage.
  • Able to work in a fast-paced, flexible, team-oriented environment.
  • Possess excellent interpersonal and communication skills (written and verbal).
  • Strong attention to detail with a view to bring studies to a quality conclusion.
  • Flexible, positive, creative thinker, good communicator.
  • Be able to work without close supervision. Well-developed time management skills are important.

Desirable

  • Bachelors or Master’s degree in Statistics or a subject with a major statistical component

 

Location: Cambridge or Homebased

To apply please send your CV with salary expectations to recruitment@gwpharm.com

Senior Medical Information Scientist, Permanent

 

Cambridge, UK

 

Job summary:

The Senior Medical Information Scientist will work as part of the Medical Information team and provide up-to-date, accurate and balanced information on products to internal and external customers. This role will a require an experienced Medical Information professional to undertake a key role in the Global Medical Affairs group to support both licenced and developmental products at this exciting time of growth for the company.

 

Responsibilities include:

  • Provide a high quality Medical Information service to both internal and external customers, record comprehensive details to the Global Enquiry Management System and operate in line with local SOPs, Copyright Law, Codes of Practice and PIPA UK guidelines.
  • Prioritise, plan and organise work considering the customer and business needs and gain expertise from Medical Affairs colleagues to facilitate enquiry conclusion and Standard Response management.
  • Escalate important issues as they arise to management colleagues and ensure adverse event and quality reporting, in compliance with Medical Affairs, PV and Quality department guidelines.
  • Applying a basic awareness of business strategy to identify enquiry trends and emerging issues and raising awareness with appropriate colleagues as well as providing input to business tenders where appropriate.
  • Ensure that product knowledge and search system skills are gained, applied and maintained and assist in developing and maintaining standard responses and procedures.
  • Working with the team to raise awareness of the Medical Information operation and processes with the broader UK and Global teams.
  • Provide training and guidance and support to junior members of the Medical Information team as required.
  • The Senior Medical Information Scientist is responsible for maintaining cGxP and H&S knowledge applicable to the job and carries out their work in a way that will not adversely affect their own, or others’, health, safety and security or the environment and reports any shortcomings in GW arrangements.
  • Work with the Medical Affairs Manager to review, improve and develop the Medical Information Department to meet changing business needs
  • Liaises with colleagues in the United States to ensure uniformity of information delivery
  • Project work to support the activities of the Global Medical Affairs group from time to time

 

Qualifications/ Experience required:

  • Degree level or above in Life Sciences, Pharmacy or related field.
  • Established Medical Information Service expertise in the pharmaceutical industry
  • Be comfortable working within a commercially-focused, fast-moving and delivery-orientated environment.
  • Experience of standard MS Office software and of Medical Information support systems.
  • Strong and fluent communication skills.
  • Develops and maintains positive working relationships with others and demonstrates a ‘can do’ approach.
  • Ability to lead, motivate and develop others both within the team and more broadly.
  • Will be an ambassador for Medical Affairs throughout GW.

Qualifications/ Experience desired:

  • Knowledge of medical information systems and pharmacovigilance and regulatory requirements.
  • A sound knowledge of both the ABPI Code of Practice and promotional copy approval systems

To apply, please send your C.V and salary expectations to recruitment@gwpharm.com

Location:  Cambridge, UK

EHS Advisor

 

Permanent – South East UK

 

The Role

To ensure the administrative management of the company’s EHS, Security System and associated software system (Mirashare) and provide EHS advisory support for all departments within the company.

 

 

Key Responsibilities

  • To be responsible for providing EHS advisory support to all departments within the organisation as directed by the EHS & Security Manager, with a specific emphasis on the management of Environmental Permits including monitoring and Waste Management Systems.
  • responsible for the day to day co-ordination of the EHS & Security function including the Mirashare EHS and Security software system.
  • This role is significant in raising the profile of EHSS with the company, ensuring that EHS practices are embedded in our ways of working, and contribute to and support change.
  • Deputise for the EHS & Security Manager in their absence. 

 

Essential Skills & Experience

Knowledge:

  • NEBOSH General Health and Safety Certificate/NVQ equivalent or Tech IOSH
  • Experience of Environmental Permitting and/or Waste Management Systems
  • Associate Membership of IEMA or similar qualification

Experience:

  • Advising at all levels of an organisation on EHS related matters
  • Using software based Management Systems e.g. Mirashare or modular based system
  • Experienced in EHS administration

Skills:

  • Good organisational skills
  • Good communication skills
  • Management of software based systems
  • IT competency - Excel / Word / Power-Point
  • Excellent attention to detail 

Location: South East, UK 

 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

BDP Process Technician

 

Permanent

South East, UK

 

The Role

 

To work as part of a Team to ensure the department delivers the product to the customer on time and in full. This covers the manufacture and filling of the bulk solution for Supply Chain and packing the labelled filled vials for the various markets supplied by GW Pharmaceuticals marketing partners.

 

Key Responsibilities

Quality is a primary focus to ensure all aspects of cGMP are met and product quality is not compromised. The workload is varied with the core areas of responsibility listed below:

  • Ensure delivery against schedule, for all BDS/BDP production batches
  • To work with the BDS/BDP Management to ensure that all personnel training, investigation and deviation actions, critical documentation and audit actions are completed on time
  • Enforce, maintain and adhere to cGMP and H&S knowledge applicable to this role
  • Where required help to ensure the successful implementation of approved projects and business plans within the BDS/BDP area and wider Production department
  • Ensure all BDS/BDP batch documentation have been processed in accordance with cGMP and current GW procedures
  • Maintain stock levels including stock cupboard checks and stock ordering to supply BDS/BDP
  • Perform routine micro testing in the CMS
  • Weekly/Specialised clean in all areas

 

Essential Skills

  • Experience in a regulated production environment within the pharmaceutical or related industry.
  • Understanding of GMP.
  • Experience of various filling and packaging machinery.

Skills:

  • Good working knowledge of Microsoft Packages i.e. Word, Excel, PowerPoint
  • Good interpersonal skills
  • High level of numeracy
  • Good communication skills including written and presentational
  • Excellent attention to detail

Location: South East, UK 

To apply please send your CV with salary expectations to recruitment@gwpharm.com

 

Clinical Research Associate – US (various locations)

 

The Role

Responsible for the day to day activities including set up, monitoring and completion of clinical trials in accordance with GW SOPs, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and relevant local and international regulatory guidelines.

 

Key Responsibilities

  • Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and Company guidelines.
  • Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
  • In accordance with GW SOPs, performs site management activities including:
    • site evaluation visits
    • site initiation visits
    • monitoring visits
    • closeout visits
  • Collaborates with the Core Project Team to drive subject recruitment
  • Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure compliance with applicable regulations and the protocol.
  • Is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Essential Skills

  • BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification and experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry.
  • Experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
  • Good knowledge of relevant GW SOP’s, ICH-GCP, The US Food and Drug Administration FDA Code of Federal Regulations Title 21 – Food & Drugs Good Clinical Practice Parts: 11, 50, 54, 56, 312 and 314  and other regulatory guidelines, as applicable.
  • Fluent in English and in the relevant native language.
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail with a proven track record for ensuring quality data and good site management.
  • Ability to travel to sites and be available for domestic and international travel including overnight stays, as required.
  • Able to use initiative and problem solve.
  • Flexible and adaptive approach to work.
  • Able to work in a team and as an individual.
  • Ability to identify issues and resolve appropriately with guidance.
  • Ability to process visit reports in a timely manner to an acceptable quality. 

 

Location – US, various locations 

 

To apply please send your CV with salary expectations to usrecruitment@gwpharm.com

 

 

GW is fully committed to achieving equality of opportunity in all its employment practices, policies and procedures irrespective of their race, ethnic origin, religion, colour, age, gender, sexual orientation, nationality, disability, or marital status. The Company does not tolerate any harassment or discrimination and every employee is highly valued and their rights and dignity are respected. The equal opportunities policy covers all permanent and temporary employees (including non-executive directors), all job applicants, agency staff, associates, consultants and contractors.

Please be aware the UK Government has taken steps to reduce net migration to the UK by limiting the number of overseas workers from outside the EEA coming to the UK for employment. Consequently, whilst we are able to consider applications from overseas workers from outside the EEA (who require a Tier 2 (General) Visa) we can only employ them if we can provide evidence that there are no other suitable candidates from inside the EEA.Therefore all Non-UK/EEA nationals’ applications will be kept on hold until we have pursued all candidates who currently have the right to work in the UK.