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.

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

Clinical Projects Assistant

 

Cambridge

12 Month FTC

 

The Role

Clinical Projects Assistants are responsible for the administration, coordination and tracking of clinical trials (Phases 1-4). Key tasks are the establishment and maintenance of paper and electronic filing systems (including TMF management), provision of support to Clinical Research Associates and Project Managers during the set-up, monitoring and close-down phases of clinical trials, assisting with ethics committee applications, liaison with suppliers and CROs, and tracking of overall project progress.

 

Key Responsibilities

  • Coordination and tracking of clinical projects.
  • Provide support to Clinical Operations Managers (COMs), Clinical Project Managers (CPMs) and Clinical Research Associates (CRAs) during the life of the clinical trial.
  • 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 cGxP and H&S knowledge applicable to the job.  

Essential Skills

  • Direct, relevant experience as a Clinical Projects Assistant or similar role in either a CRO or Pharmaceutical business.
  • Knowledge of relevant regulatory guidelines and legislation.
  • Experience of Coordinating and tracking of clinical projects.
  • 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.
  • Working knowledge of MS Outlook, Word, Excel and PowerPoint.

 

Location: Cambridge

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

Production Line Lead - Permanent

 

South East, UK

 

The Role

 

The Line Lead is responsible for processing Botanical Raw Material (BRM)/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.

Where appropriate, this role will also include direct people management responsibilities including individual/team performance management.

 

Key Responsibilities

  • Provides day-to-day leadership, support and direction to the team, to include dealing with routine staffing matters occurring within their team, referring issues up the line as required.
  • Process manufacture of BRM/BDS.
  • Responsible for the operation of their team, ensure all direct reports are suitably trained and have adequate resources to complete their operations.
  • Authoring and reviewing of batch documentation and Standard Operating Procedures (SOP).
  • The Production Department is subject to regular visits by senior management, external bodies and regulatory authorities. The Line Lead will be called upon to conduct tours of the BDS Production Facility.
  • Completing/reviewing deviations and change controls that may occur during the running of BDS Production Departments.
  • Compiling the Home Office returns and liaising with other departments to ensure that the figures are correct.
  • The Line Lead must schedule departmental workloads to meet capacity targets.
  • Liaising with other departments on BDS Production scheduling matters (including processing BRM/BDS requests).
  • The Line Lead will be expected to allocate final BDS to the BDP Production Department by assessing the suitability of the BDS based on knowledge of events during manufacture, expiry dates and any other requirements specified within procedures.
  • The Line Lead is trained and authorised to sign for documents in the absence of the Production Manager/Extraction Manager/BDS Team Leader.
  • Act as key Point of Contact (POC) for all key stakeholders (groups), in the absence of the Production Manager/Extraction Manager/BDS Team Leader.
  • Training of –other Technicians on new processes/changes to manufacturing techniques.
  • Identifying areas for improvement and implementing these improvements, where applicable across all BRM/BDS Production processes/working practices.

 

Essential Skills

  • Experience gained in a regulated production environment, ideally within the pharmaceutical/chemical or food industry.
  • Has the ability to provide leadership, support and direction to the team.
  • Good level of numeracy.
  • Good communication skills including written.
  • A good working knowledge of standard Microsoft packages, i.e. Excel and Word.
  • Excellent attention to detail.
  • Develops and maintains positive working relationships with key stakeholder groups, both internal and external.
  • Ideally hold qualifications gained in the Pharmaceutical industry i.e. NVQ’s, or similar.
  • Proven experience of team supervision or leadership in Pharmaceutical or related industry.

 

Location: South East, UK 

 

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

 

Learning & Development Manager – Cambridge or South East, UK

 

Permanent

 

The Role

The role is responsible for the design, delivery and evaluation of the GW learning and development strategy.

 

Key Responsibilities

  • The role is accountable for developing a learning and development strategy for GW and for identifying, implementing and monitoring the impact of the learning when set against GW’s vision and strategic priorities.
  • The role holder will be responsible for building and maintaining key relationships with senior stakeholders, managers, the broader HR and Compliance Training teams in order to identify and respond to short, medium and long-term learning and development needs for individuals, teams and the organisation.

 

Essential Skills & Experience

Knowledge and Experience

  • Must have strong experience of delivering high quality training solutions within the pharmaceutical and/or biotech sector. This must include exposure to developing and implementing learning and development strategies.
  • Recent experience of implementing and delivering leadership and managerial training to managers and senior executives is essential.
  • Has managed the full learning and development cycle.
  • Experience of running sessions at senior management level and above.
  • Experience of creating and managing budgets.
  • Experience of partnering with external suppliers and has wide contacts within the industry.
  • Experience of how to engage with a global population and an understanding of the unique challenges of creating pragmatic learning and development solutions within a fast-paced, multi-site operation.
  • Familiarity with a broad range of training methods.
  • Experience of building strong relationships with senior stakeholders.
  • Experience of using psychometric tools in a learning and development setting.
  • Experience of coaching leaders and staff to excel in their roles.
  • Working experience in the use of Learning Management Systems.

Skills, Attributes and Behaviours

  • Delivery-focused and commercially minded.
  • A strong and articulate communicator.
  • A confident delivery style; can stand up and deliver fluently to a range of audiences, including senior executives.
  • Highly developed coaching, mentoring and facilitation skills.
  • Highly PC literate working with MS Office and particularly PowerPoint.

Location: Cambridge or South East, UK 

 

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

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

Accounting Manager  

Carlsbad, CA

 

About the Role:

This role will help build and execute financial reporting and transactional activities with the finance and accounting group.  The successful candidate will have experience building strong foundations within rapidly growing organizations and be able to flex between building process and operational work. 

 

Responsibilities:

  • Prepare monthly financial statements, metrics, and actual vs. budget variance reports
  • Manage and process Accounts Payable
  • Manage and process multi-state Payroll
  • Manage and process stock option activity
  • Manage and file federal, state and local business and tax filings as needed
  • Establish and maintain internal controls to support the financial infrastructure, in accordance with SOX requirements  
  • Ensure policies and procedures are in compliance with professional standards, state and federal regulatory requirements
  • Other duties are required and/or assigned

 

Requirements:

  • Bachelor’s degree in Accounting or Business with an emphasis in accounting
  • Previous SOX experience required
  • CPA preferred
  • Experience in Public Accounting a benefit
  • Previous start up and pharmaceutical experience highly preferred
  • Strong financial and accounting competence including planning, analysis, accounting principles, and payroll
  • Strong communication skills
  • Demonstrated ability to build trusting and credible relationships throughout an organization
  • Outstanding organizational and time management skills
  • Ability to be flexible in response to change

 

Please send your C.V and salary expectations to usrecruitment@gwpharm.com

QC Scientist - South East, UK - Permanent

 

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

  • Perform analytical testing using GC, HPLC, TLC, FTIR and other required techniques in accordance with written procedures
  • Qualification of Laboratory instruments and validation of analytical methods
  • Provide clear and accurate records of all work performed
  • Ensures that all analytical operations are performed in accordance with current cGMP regulations
  • Record data into appropriate records and notify the line manager of any OOS, OOT, OOE or questionable results
  • 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
  • Experience of working in a pharmaceutical or other regulated laboratory
  • 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

Pharmacology Project Manager – Permanent – Cambridge UK

Job summary:

Overall management of GW and CRI pharmacology programmes from study design to study report finalisation and subsequent publications

Responsibilities include:

  • Management of GW and CRI pharmacology studies / programmes across all therapeutic areas as determined by the needs of the organisation.
  • Propose and manage timelines for pharmacology studies.
  • Ensure studies are run in accordance with the appropriate GW or researchers SOPs and relevant regulatory guidelines and legislation.
  • Maintenance of good working relationships with key opinion leaders and researchers.
  • Design and deliver internal training and inductions.
  • Define and manage study / programme resource needs and establish contingency plans for key resources.
  • Manage the material requirements for the GW / CRI pharmacology programmes to ensure that materials are always available as appropriate.
  • Manage scientific reports form academic collaborators and CROs.
  • Contributes to regulatory documents as required to meet corporate needs.

Qualifications/ Experience required:

  • A Higher degree (PhD or MSc) in Pharmacology or another appropriate scientific discipline.
  • Previous experience in a similar role
  • Research experience in an academic or industrial environment.
  • Experienced in scientific writing.
  • Experienced in presenting key data at national and international meetings and symposia.
  • General understanding of budgetary control.
  • Organisational skills and the ability to prioritise.
  • Ability to use initiative and problem solve.
  • Ability to lead, direct, manage, motivate and develop others.
  • Report writing skills.
  • Communication skills.
  • Written and Verbal presentation skills.
  • Excellent attention to detail.
  • Working knowledge of Excel, Word, PowerPoint, Endnote, search engines and databases used for literature.
  • Demonstrates a pragmatic approach to problem solving.
  • Self-motivate approach, with a willingness to assist colleagues to achieve goals

Desirable

  • Knowledge of cannabinoid pharmacology and the endocannabinoid system.
  • General knowledge of the drug development process.
  • Knowledge of relevant SOPs, regulatory guidelines and legislation.  

 

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

 

Bioanalytical Manager – Cambridge UK – Permanent

 

An excellent opportunity has arisen to work within an innovative research-based pharmaceutical company specialising in unique medicines. We are seeking an experienced, motivated and talented individual, working within our clinical operations team.

 

The role will primarily involve the management of bioanalytical analysis for our entire development pipeline and overseeing the conduct and reporting  to ensure compliance with GxP regulations and company SOPs.

 

The Role

The role of the Bioanalytical Manager is to manage the integrated GW preclinical and clinical bioanalytical programmes.

The conduct of preclinical and clinical GXP and non-GXP studies will be the responsibility of the clinical or preclinical Project Manager.  The Bioanalytical Manager will support these studies for all bioanalytical related tasks.

 

Key Responsibilities

  • Liaises with Preclinical and Clinical to identify individual validation, bioanalytical requirements to support GW development programmes
  • Plans and executes and reports the validation of bioanalytical methods required to support GW development programmes in a timely manner
  • Manages the supply and synthesis of materials required for analysis of GW bioanalytical samples
  • Works with Clinical, Preclinical, Contract Management and Quality departments to select new bioanalysis vendors and institute appropriate governance structure.
  • Manages the bioanalytical study support by vendors to ensure   tasks are completed to development timelines and within budget..
  • Coordinates bioanalytical vendor governance between GW and vendors.

 

Knowledge:

  • A graduate degree in a Science/Life Science discipline or another appropriate scientific discipline

Experience:

  • A high level of technical knowledge in bioanalytical techniques
  • bioanalytical experience within the pharmaceutical, biotechnology and/or contract research organisations
  • Strong scientific background and excellent bioanalytical knowledge and writing skills
  • Knowledge of GxPs, ICH guidelines and requirements for the successful set up, validation and conduct of bioanalytical studies
  • An understanding of bioanalytical support within the pharmaceutical industry
  • An understanding of ADME & metabolite identification
  • An understanding of bioanalytical techniques (e.g. HPLC-MS/MS)
  • An understanding of the pharmaceutical industry

 

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

 

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

QC Team Leader


South East, UK

 

The Role

 

Reporting to the QC Manager, the QC Team Leader will manage the day to day work of a team of analysts.  The role will include scheduling work, checking & reporting of results, release of products, qualification of equipment and/or methods, and any other customer requirements for the areas of responsibility assigned. 

 

Key Responsibilities

  • To supervise, train, and mentor QC team members and ensure that they work to cGMP at all times. 
  • Planning, prioritising, and managing the QC analysis for the areas of responsibility by co-ordinating with other QC Team Leaders, QC Manager, and other departments (customers)
  • Ensures that all analytical operations are performed in accordance with current cGMP regulations
  • Participates in the continuous trending, communication, and review of batch data
  • Checking of analytical data and results, ensuring that they are clear, correct and in compliance with procedures, specification limits and cGMP requirements.
  • Leading and documenting laboratory OOS, OOE and OOT investigations, and deviation investigations, identifying the root causes of problems and introducing effective corrective and preventative actions
  • Qualification of Laboratory instruments and validation of analytical methods
  • 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
  • Training in, and experience of, leading a team in a pharmaceutical or other regulated laboratory
  • High level of knowledge and understanding of cGMP regulations
  • Experience in analytical method validation, instrument qualification, and CSV requirements
  • Knowledge and understanding of data integrity requirements
  • High level of knowledge and experience of QC analytical testing and the use, and troubleshooting of, analytical instrumentation
  • Knowledge of stability testing and associated guidelines
  • Experience of Pharmacopoeial testing and the use of Pharmacopoeias
  • 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
  • Experience in the use of and data interpretation from GC-MS and LC-MS
  • Knowledge and experience of testing natural products in a cGMP environment

 

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 Coordination Manager

 

Carlsbad, CA

 

About the role:

The Clinical Coordination Manager will be responsible for the administration of clinical projects in the United States in support of Clinical Operations objectives and the global Clinical Coordination Department.

 

Responsibilities:

  • Coordination and tracking of clinical projects.
  • Provide support to Clinical Operations Managers (COMs), Clinical Project Managers (CPMs) and Clinical Research Associates (CRAs) during the life of the clinical trial.
  • Set up and maintenance of paper and electronic trial filing systems.
  • Assist in development of Clinical Coordination systems and procedures.
  • Line management of one or more CPA or other CCD staff
  • 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.
  • Coordination of submissions/responses and tracking approvals and progress.
  • 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.
  • Attends CRA meetings, project team meetings and trial specific meetings and reports on trial progress as required.
  • Update Central Laboratories, Interactive Voice Response System (IVRS), Electronic Data Capture (EDC) and other service providers with site contact information (as requested).
  • Set-up and maintain Trial Master Files in accordance with company Standard Operating Procedures (SOPs) and International Conference on Harmonization (ICH) GCP.
  • Ensure electronic trial filing is completed.
  • Write and review Clinical Coordination SOPs as required.

Requirements:

  • Experience in the pharmaceutical industry.
  • Good interpersonal skills – including oral and written communication skills.
  • 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.
  • Direct experience of line management, or of mentorship.

Please send your C.V and salary expectations to usrecruitment@gwpharm.com

CTS Distribution Specialist

 

South East, UK

Permanent

 

The Role

To coordinate specific functions of the Clinical Trial Supplies Department, as identified below ensuring effective and efficient delivery, in a timely manner and in accordance with Good Manufacturing Practice, Good Clinical Practice and Good Distribution Practice.

.

Key Responsibilities

  • To be one of the Subject Matter Experts in Import and Export activities for the department.
  • Depot Set up and Management
  • To act as a contact for new depot requirements for clinical trial studies.
  • Prepare Clinical Trial consignment documentation to GxP standards as required.
  • The role holder is responsible for the preparation of the physical consignment.
  • Contribute to Trial Master File process
  • Coordination of Investigator Initiated Trial’s
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job 

Essential Skills & Knowledge

Knowledge:

  • Good knowledge of clinical trial process.
  • Project planning
  • Previous experience of shipping Controlled Drug and restrictive storage conditions  

Experience:

  • Experience working in a Pharmaceutical or other regulated industry is essential.
  • Specific experience within a GMP clinical trial supply environment.
  • Experience of Import and Export; obtaining licenses and shipping documentation
  • Excellent communication skills, both written and oral
  • Experience of shipping  cold chain, ambient and controlled drug shipping
  • Experience of shipment tracking and maintaining audit trail of IMP and ancillary items.
  • Liaising with couriers and third party depot communications

Skills:

  • A good working knowledge of Excel
  • High level of numeracy
  • Communication skills including written and presentational
  • Excellent attention to detail
  • Excellent knowledge of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) & Good Distribution Practice (GDP)

 

Location: South East, UK

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

Clinical Compliance Officer

 

Cambridge, UK

FTC - 12 months

 

The Role

Process improvement is a key focus within GW Clinical Operations, and the Clinical Compliance Officer is empowered to identify, develop and drive the implementation of new ways of working. They will have a solid understanding of clinical trials, and the ability to critically evaluate, refine and communicate processes.

 

Key Responsibilities

  • Drive Corrective and Preventative Action (CAPA) development and resolution across Clinical Operations
  • Recognise, develop and implement cross-functional process improvements
  • Support preparation for audits and inspections
  • Drive SOP updates and implementation
  • Establish system/process training needs, develop materials and deliver training
  • Promote compliance with regulations, SOPs & guidelines

 

Essential Skills

  • Substantial experience working in clinical trials environment
  • Knowledge of GCP and current regulations governing clinical trial conduct
  • Degree in Biological Science/Nursing Qualification or equivalent - preferable
  • Experience of inspections and audits
  • Ability to influence/motivate colleagues, and to promote effective team working
  • Flexible and adaptable to a fast-changing environment
  • Strong communication skills (written and oral)
  • SOP writing
  • Root cause analysis and CAPA development
  • Computer literate in Microsoft packages
  • Excellent time management and organisational skills

Location: Cambridge, UK

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

BDS Process Technician, South East, UK

 

Permanent

 

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.

The BDS Process Technician will also have the responsibility of being the back-up for the BDS Production Line Lead in their absence. Working hours are 08:00 – 16:30.

 

Key Responsibilities

  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
  • Process manufacture of BDS.
  • In the absence of the BDS Production Line Lead, provide day-to-day leadership, support and direction to the team, to include dealing with routine staffing matters occurring within their team, referring issues up the line as required.
  • In the absence of the BDS Production Line Lead, Compiling the Home Office returns and liaising with other departments to ensure that the figures are correct.
  • 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.
  • Completing/reviewing deviations and change controls that may occur during the running of BDS Production Departments.
  • Authoring and reviewing of batch documentation and Standard Operating Procedures (SOP).
  • The Job Holder maybe called upon to provide cover for other internal departments, when the BDS Production schedule allows.
  • The Production Department is subject to regular visits by senior management, external bodies and regulatory authorities. The BDS Process Technician will be called upon to conduct tours of the BDS Production Facility.
  • Identifying areas for improvement and implementing these improvements, where applicable across all BDS Production processes/working practices.
  • Training of –other Technicians on new processes/changes to manufacturing techniques.
  • Act as key Point of Contact (POC) for all key stakeholders (groups), in the absence of the Production Manager/Extraction Manager/BDS Team Leader.
  • Completing additional tasks assigned by Production management that are outside the core duties described above 

Essential Skill 

  • 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.
  • Develops and maintains positive working relationships with key stakeholder groups, both internal and external.
  • Prepared to challenge the norm and look for areas of improvement, share own ideas and information.
  • Good Team worker assists colleagues as and when required.
  • Demonstrates a ‘can do’ attitude. 

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

Senior Clinical Quality Assurance Auditors – Cambridge or Field Based –12 & 18 month FTC

 

The Role

  • To provide objective assurance to GW management through the preparation, performance, reporting and follow-up of independent clinical quality assurance audits, that clinical trials are conducted in compliance with the relevant GxP guidelines, regulations and GW or other applicable standard operating procedures (SOPs).
  • To support operational staff through advice and training related to specific area of GxP, regulations and process knowledge and to identify process improvement opportunities through SOP review and audit activities.

 

Key Responsibilities

  • To assist the Clinical Quality Assurance (CQA) Manager with the set-up, implementation and conduct of the CQA audit programme.
  • To act as audit programme lead for an assigned audit programme.
  • To report audit findings to the CQA Manager and the client groups in accordance with company SOPs.
  • To assess the appropriateness and monitor the implementation of corrective and preventative actions (CAPA) arising from audits and track to satisfactory closure.
  • To assist with the preparation for inspection readiness and hosting of regulatory inspections and external party audits of GW (e.g. partners).
  • To assist with the preparation for GCP inspections conducted by national and international regulatory authorities and other external bodies such as marketing partners. 
  • To assist the CQA Manager with the promotion of quality awareness among company personnel and assist with the development and maintenance of company GxPs and quality standards by means of a training, review, advice and guidance service.
  • To identify and communicate quality improvements in GxP activities.
  • To provide day to day support, mentoring and training to other members of CQA in GCP audit techniques, with the production and implementation of training programmes and assessing competency where appropriate.
  • To maintain current GxP and Health & Safety knowledge applicable to the job.

 

Essential Skills

Knowledge

  • A Bachelor’s degree in a scientific discipline or nursing degree
  • ICH-GCP international regulations and guidance, with the ability to apply this knowledge to resolve day-to-day issues.

 

Experience

  • Previous GCP auditing experience from working in a Pharmaceutical company or other regulated industry.

 

Skills

  • Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and to work effectively in a multi-disciplinary team.
  • Good organisational skills, with the ability to multi-task, including the ability to work independently or as part of a team, to agreed deadlines.
  • Excellent attention to detail and the ability to identify the root cause of problems.
  • Competency in Microsoft office, Word, Excel, Powerpoint
  • High level of numeracy

 

Desirable Skills

Knowledge

  • Quality Assurance / Quality Management qualifications.
  • GxP international regulations and guidance, with the ability to apply this knowledge to resolve day-to-day issues.
  • European, United States and UK regulatory requirements.
  • Pharmaceutical regulatory standards in clinical research and international regulatory requirements for product registration.

 

Experience

  • GCP auditing experience working in a healthcare company or CRO, with demonstrated knowledge and experience of audit and inspection techniques
  • Experience of auditing Pharmacovigilance activities

 

Skills

  • Competency in use of electronic systems for management and tracking of audits, audit reports, CAPAs.

Location: Cambridge or Field based

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

Senior Manager/Associate Director of Regulatory Affairs – Carlsbad, CA

 

The Role

To write, submit, and maintain US applications (INDs, ODAs, and NDAs) for products in development and approved products according to ICH and FDA regulations.

 

Key Responsibilities

  • Plans, coordinates and participates in writing, preparation, assembly, and maintenance of US applications to regulatory authorities
  • Creates and manages submissions 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 

 

Essential Skills

  • Bachelor of Arts/Science degree in a relevant discipline
  • Extensive regulatory strategy and project management experience
  • Extensive experience and interactions with FDA on drug development programs, including organizing and leading meetings with FDA
  • Knowledge of FDA and ICH guidelines and up to date training on SOPs 

 

Desirable

  • Additional higher educational qualification, such as a Master’s degree or PhD. 

 

Location:  Carlsbad, CA 

 

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