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. The Group's lead programme is the development of a product portfolio  of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic indications, including Sativex® Oromucosal Spray and Epidiolex® for childhood epilepsy.

 

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.

Quality Control Scientist

 

Permanent

 

The Role

The role entails the analysis of pharmaceutical materials, APIs and finished products to ensure compliance with internal and regulatory specifications.  Daily tasks will involve in general chemical analysis including stability testing, documenting analytical data and reporting results in accordance with cGMP.

 

Dependant on experience, the role will either be at the Analyst or Technician level.

 

Key Responsibilities

  • Chemical and physical analysis of materials, active ingredients and finished products, including stability testing
  • Documenting analytical data and results according to cGMP
  • Creating and updating Standard Operating Procedures and Test Methods
  • Training of staff, where appropriate
  • Maintaining and calibrating analytical instruments as required
  • Ensuring the laboratory is maintained in a clean and tidy manner at all times

 

Essential Skills

  • Strong attention to detail in a highly regulated environment. 
  • Analytical thinking, concern for quality, excellent organisational and communication skills, and the ability to operate effectively within a busy team whilst building relationships within the organisation
  • Proven competence in analytical techniques, especially HPLC, GC, FTIR, UV, and wet chemistry testing. 
  • Chemistry graduate (or equivalent) with knowledge and experience of working in a GMP environment.  Or experience of working in a similar role
  • Knowledge of stability and Pharmacopoeial testing would be advantageous.

Location: South East 

 

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

Warehouse Operative

 

12 Month fixed term contract

 

The Role

To receive, store and distribute materials and products across the site and dispatch of product and materials to customers and partners.

 

Key Responsibilities

  • Receiving of materials from suppliers
  • Booking In of materials to be stored within the warehouse
  • Picking and delivery of materials to internal customers across the site
  • Receiving of finished product and storing in appropriate storage locations
  • Maintenance of stock records
  • Material and finished goods cycle counting
  • Support six monthly stock checks
  • Provide Supply Chain Department support as required
  • Assist with commercial shipments to marketing partners
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job
  • Supporting both domestic and international product shipments
  • Support for out of hours call outs for Supply Chain plant alarms

 

Essential Skills

  • Experience in a similar Supply Chain position
  • Knowledge of a broad-base of supply chain functions and disciplines
  • Pharmaceutical industry experience desirable
  • Fork Truck Licence
  • Self-motivation and exceptional commitment
  • Excellent interpersonal and communication skills
  • Attention to detail and delivery of accurate data
  • Knowledge of IT systems and software including ERP (Enterprise Resource Planning) software and MS Office software especially Excel

 

Location: South East 

 

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

 

Technical Writer

 

12 month fixed term contract

 

The Role

Responsible for the publishing and formatting of clinical and regulatory documents to ensure internal consistency, quality and formatting requirements to meet regulatory submissions.

 

Key Responsibilities

  • Proofing and formatting a wide range of documents produced by the R&D Departments.
  • Maintaining and updating clinical writing templates and guidelines such as protocols and CSRs.
  • Conducting quality control checks of clinical documents and follow-up with authors any findings.
  • Supporting medical writing team in the coordination of clinical document review, publication submissions and ClinTrials registration.

 

Essential Skills

  • Previous pharmacovigilance experience or a medical science/nursing background would be desirable
  • Excellent attention to detail with the ability to identify the root cause of issues.
  • Must be fluent in written and spoken English.
  • Good knowledge of GCP, EMEA and FDA regulations or other regulatory guidelines.
  • Comprehensive computing skills in particular in the use of Microsoft Office applications.
  • Excellent organisational skills.
  • Able to work independently or as part of a team.
  • Good at multi-tasking and working to agreed deadlines.
  • Ability to build effective working relationships with a number of different departments.
  • Previous experience of clinical trials would be a definite advantage.

 

Location: Home based – with travel to various UK sites

 

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

Senior Statistician

 

12 Month fixed term contract

 

The Role

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

 

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.

 

Essential Skills

  • Relevant experience – within clinical CRO or pharma, i.e. producing/QCing SAPs, programming/QC of derived datasets and TFLs in SAS.
  • Good programming abilities and willing to help out with programming.
  • Flexible and able to work on a variety of tasks from programming, SAP production, review of statistical documents, preparing for blinded data review meetings.
  • Masters degree in Statistics or a subject with a major statistical component
  • Good knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
  • Proficient in the use of computers and especially the SAS system.  

 

Location: Cambridge 

 

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

Data Manager

 

12 Month fixed term contract

 

The Role

The role of the Data Manager is to perform all entry level Data Management activities ensuring efficiency, accuracy and quality. The role may include reviewing data spreadsheets and generating queries, data entry, QC and some basic SAS programming (depending on experience) as appropriate.

 

Key Responsibilities

  • Perform all tasks in adherence to GCP.
  • Review periodic data spreadsheets from sites and generate queries to ensure the data is in the correct format for reporting and is clean.
  • Timely and accurate data entry of Case Report Forms.
  • Importing of spreadsheets into SAS and generating basic T&Ls (depending on experience).
  • Quality Control (QC) checking of data entered by others and reviewing listings against source spreadsheets.

 

Essential Skills

  • Basic understanding of Clinical Data Management processes
  • Good Knowledge of ICH - GCP guidelines
  • Knowledge of Excel and Word is essential
  • Good computer skills
  • Competent in oral and written English
  • Commitment to consistent high quality work

Desirable Skills

  • Knowledge of applying ‘Data Validation’ and ‘Protection’ of certain cells within Excel
  • Some experience with SAS programming would be an advantage

Location: Cambridge

 

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

 

 SOX Reporting Accountant

 

12 months FTC

 

The Role

Lead improvements to the Group’s Sarbanes Oxley (“SOX”) compliance.

 

Key Responsibilities

  • Be fully responsible for improvements to SOX compliance.
  • Liaise with the Chief Financial Officer and the Audit Committee to assist the business with SOX compliance and to ensure all elements of the improvement project are executed to plan.
  • Review and manage all documentation produced in scope locations, ensuring consistent quality across the Group.
  • Identify and lead improvements to the Group’s SOX documentation and approach.
  • Plan, manage and execute a rolling programme of SOX testing.
  • 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

 

Essential Skills

 

Knowledge:

  • A detailed knowledge of the Sarbanes-Oxley Act;
  • A high level of SOX experience

 

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.

 

Desirable:

  • Experience of working in a US-listed company would be highly desirable
  • Knowledge of implementing a Sarbanes-Oxley compliant set of controls would be advantageous
  • Chartered/certified accountant or similar internal audit qualification
  • Experience of Microsoft Navision accounting systems would be preferable
  • A thorough knowledge of core Microsoft Office products

 

Location: Flexible – with UK travel

 

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

Pharmacovigilance Assistant

 

Permanent

 

The Role

Working in our global Pharmacovigilance Department the candidate will provide essential administrative support to the Pharmacovigilance Director and Pharmacovigilance Team through organising, planning, receiving and distributing communications for essential activities.  Accurately processing case safety reports and tracking compliance and reconciliation activities.

 

Key Responsibilities

  • Assistant to the Pharmacovigilance Director (providing administrative support, arranging travel, organising expense claims and raising Purchase Orders).  Additionally answering phone calls/enquiries and taking messages.
  • Coordinate administrative activities of the department including meeting planning, taking minutes and following up on actions.
  • Monitoring safety follow-up queries with clinical study sites and also post-marketing Safety follow-up with GW’s marketing partners.
  • Tracking and coordinating case reconciliation activities.
  • Scanning, triage and data entry of safety cases including study CRFs.
  • Maintaining safety study filing systems in cooperation with other departments.

 

Essential Skills

  • Previous administrative experience, preferably in the Pharmaceutical Industry.
  • Competent with medical terminology, an excellent organiser and communicator and possess good IT skills. 
  • Demonstrates highest level of confidentiality and discretion.
  • This is an excellent opportunity for a candidate seeking to develop / broaden their knowledge within a Pharmacovigilance setting.

 

Location: Cambridge

 

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

Pharmaceutical Development Technician

 

12 month fixed term contract

 

The Role

Assist in the manufacture of pharmaceutical formulations.

 

Key Responsibilities

  • Assist in manufacture of preclinical and clinical formulations.
  • Assist in the maintenance of the Pharmaceutical Development Manufacturing Facility.
  • Assist in maintenance of preclinical and clinical consumables.
  • Assist in the departmental controlled drug reconciliation.
  • Equipment validation and calibration.
  • Write and maintain GMP documents, for example batch records, deviations & SOPs.
  • Preparation of stability protocols and maintenance of in-house stability systems.
  • Assist with the management of everyday activities within the Pharmaceutical Development Department.
  • Responsible for maintaining cGxP and H&S knowledge as applicable.

 

Essential Skills

 

Knowledge:

  • Degree in an appropriate scientific qualification.

Experience:

  • If no degree - experience working in Pharmaceutical Development and/or manufacturing environment where principles of GMP are adhered to.

Skills:

  • Ability to work independently
  • Working knowledge of Microsoft Word and Excel
  • High level of numeracy
  • Strong written and verbal communication skills
  • Excellent attention to detail

Attributes and Behaviours:

  • Develops and maintains positive working relationships with others
  • Shares ideas and information
  • Assists colleagues as and when required
  • Demonstrates a ‘can do’ approach while ensuring quality is maintained

 

Location: South East

 

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

 

Regulatory Specialist - Clinical Trials

 

Permanent

 

The Role

  • Manage specified aspects of Regulatory work with a focus on clinical trial submissions for GW’s development programme
  • Assist in all aspects of Regulatory work at GW

 

Key Responsibilities

  • Management and support of Clinical Trial Applications
  • Building and maintaining relationships with other functions within GW
  • Maintaining and development of Regulatory Systems and administrative activities
  • Maintaining cGxP and H&S knowledge applicable to the job
  • Other duties as required
  •  

Essential Skills

  • Degree in a Life Science
  • Previous experience of clinical trial applications in the European Union
  • Good organisational skills
  • Communication skills including written and presentational
  • IT competency

 

Location: Cambridge

 

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

Deputy Computer Systems Validation Manager

 

12 month fixed term contract

 

The Role

To work with the CSV Manager to ensure computerised systems are in compliance with the relevant pharmaceutical regulations, guidelines and practices.

 

Key Responsibilities

  • Ensure that computer systems and their use comply with the regulatory requirements (including guidelines and current practice).
  • Assist with queries regarding computer systems operation, development and validation during regulatory and due diligence inspections.
  • Assist in the audit, review, development and implementation of computerised systems to assure they meet required standards of quality and compliance.
  • Able to sign documents in the role of CSV Management review and approval.

 

Essential Skills

  • Educated to Degree Level or equivalent in an IT or scientific discipline.
  • Relevant experience in a role directly associated with pharmaceutical computer systems validation practices.
  • Knowledge and understanding of GxPs and other relevant regulations, the drug development process and the importance of quality.
  • Highly computer literate with experience of the system design lifecycle, project management and development of qualification documentation in a regulated environment.
  • Experience of interfacing with IT contractors/developers and/or suppliers contracts and management.
  • Ability to develop pragmatic, innovative approaches to infrastructure qualification within regulatory constraints.
  • Good organisational skills, meticulous and methodical, confident in nature with skills in assertion, negotiation, influencing, tact and diplomacy.
  • Knowledge and experience of the principles of GAMP and FDA 21 CFR Part 11.

 

Location: South East 

 

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

Pharmaceutical Development Supervisor

 

Permanent

 

The Role

Reporting to the Clinical Trials Manufacturing Team Leader, the successful candidate will be responsible for the supervision of clinical trial test article manufactures, overseeing a small team of technicians in the day-to-day manufacturing tasks and facility maintenance. Due to the developmental nature of this position the successful candidate must be able to confidently direct the team in the resolution of manufacturing issues, deviations and implementation of corrective and preventative actions to ensure product quality.

 

Key Responsibilities

  • Supervise and assist in the manufacture of clinical formulations.
  • Assist in the planning and scheduling of clinical manufacture activities.
  • Assist in the management of the Manufacturing Facility.
  • Assist in the maintenance of clinical consumables.
  • Equipment validation and calibration.
  • Lead investigations, for example Deviations, OOE, OOT and OOS investigations.
  • Write and maintain GMP documents, for example batch records & SOPs.
  • Preparation of stability protocols and maintenance of in-house stability systems.
  • Responsible for maintaining cGxP and H&S knowledge as applicable.

 

Essential Skills

Knowledge:

  • Degree in Scientific Discipline

 

Experience:

  • If no degree -  experience of working in Pharmaceutical Development and/or manufacturing environment.
  • Experience in supervising manufacturing activities.

 

Skills:

  • Ability to work independently
  • Ability to supervise personnel during manufacturing activities
  • Working knowledge of Microsoft Word and Excel
  • High level of numeracy
  • Communication skills including written and presentational
  • Excellent attention to detail

 

Attributes and Behaviours:

  • Develops and maintains positive working relationships with others
  • Shares ideas and information
  • Assists colleagues as and when required
  • Demonstrates a ‘can do’ approach while ensuring quality is maintained

 

Location: South East

 

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

 

Purchase Ledger Supervisor

 

12 month Fixed Term Contract

 

The Role

The accounts team is looking for a Purchase Ledger Supervisor to lead the day to day tasks of the purchase ledger team and help drive process improvements. This role will be working closely with all members of the accounts departments and other teams within the company.

 

Key Responsibilities

  • Supervising a team of 2 to ensure invoices are processed, suppliers are paid on time and statements are reconciled
  • Authorise and approve invoices, including liaising with key staff in other departments, in time for payment run and month end deadlines
  • Carry out the first review of payment runs
  • Assisting the accounts team with any ad-hoc tasks
  • Assist with the implementation of the procurement system, authorise procurement invoices
  • Various one off project work, including reviewing existing processes and suggesting improvements where possible 
  •  

Essential Skills

  • Previous multi-company and multi-currency purchase ledger experience
  • AAT qualified preferable
  • C or above in GCSE Maths and English
  • A good understanding of Microsoft excel

Desirable Skills

  • Previous team management experience
  • Organising and filing of documents
  • Office environment experience
  • Knowledge of Microsoft NAV would be preferable
  • Ability to develop and maintain positive working relationships with others
  • Willingness to assist colleagues as and when required
  • Good communication skills including written and verbal
  • Attention to detail
  • Demonstrates a ‘can do’ approach
  • A positive attitude to change

Location: Andover

 

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

 

Senior Device Engineer

 

Fixed Term Contract - 18 months

 

The Role

Project Management of internal and outsourced device development projects.

 

Key Responsibilities

  • Manage/ Progress device development.
  • Departmental activities - write, review and approve SOPs, Maintain development laboratory as per GLP (ensure equipment and instruments are maintained and calibrated).
  • Follow cGxP, ISO 13485, Regulatory Guidelines and H&S applicable to the job.

 

Essential Skills

Knowledge:

  • A degree within an engineering or relevant scientific discipline
  • Masters in Scientific discipline (medical engineering preferably)
  • Preferably higher level qualification (PhD) (medical engineering related)
  • An excellent understanding of medical device development processes compliant with ISO 13485, QSR or experience of a similar quality system such as ISO 9001
  • Knowledge of device development within the medical device industry. 

Experience:

  • Able to manage a team to ensure smooth running of projects within the department.
  • Experience in taking a medical device from concept through to launch, including scale-up  and transfer to manufacture
  • Leading risk management process to ISO 14971. 

Skills:

  • A good working knowledge of Microsoft Word, Excel, powerpoint, and Microsoft projects (preferable)
  • High level of numeracy
  • Communication skills including written and presentational
  • Excellent attention to detail

 

Location: South East 

 

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

Toxicology Project Manager

 

Permanent

 

The Role

Will primarily entail the design, management and reporting of toxicology and safety pharmacology studies to GLP regulations and company SOPs. Excellent writing skills are required for contribution to technical sections in regulatory submissions such as Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), New Drug Application (NDA) market Authorisation Application (MAA) and Investigator Brochures (IB). The successful candidate will also participate in Product Development Plans for pipeline compounds.

 

Duties

  • Design, set up, conduct, tracking and reporting of toxicology and safety pharmacology studies and other preclinical studies as necessary.
  • Ensure that the internal and external stakeholders (e.g. GW staff, researchers or Development Partner personnel) are fully informed of study requirements and progress.
  • Ensure that appropriate documentation is in place for the set up and conduct of GW studies.
  • Preclinical study design and protocol development.
  • Evaluation and selection of CROs, placement and management of studies.
  • Monitor conduct of studies, and participate in the interpretation of study results and finalisation of the final study report.
  • Assist in forecasting and tracking of time lines and budgets
  • Manage the material requirements for the GW pharmacology programmes to ensure that materials are always available.
  • Manage appropriate bioanalytical methodologies and long term stability studies  to support the preclinical programme.
  • Ensure good laboratory practice (GLP) compliance in accordance with relevant legislation / guidance and GW departmental SOPs applicable to such studies.
  • Ensuring non-regulated preclinical studies are run in accordance with the appropriate GW SOPs and relevant regulatory guidelines and legislation.
  • Contribute towards the maintenance of the preclinical departmental SOPs
  • Participate in GW Product Development Plans.
  • Prepare relevant sections of documents for regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), New Drug Application (NDA) market Authorisation Application (MAA) and Investigator Brochures (IB).
  • Contributes to update of GW Data Packages.
  • Participate in appropriate therapeutic area training to educate the preclinical team and other GW departments in toxicology and pharmacology.

 

The successful candidate will have the following skills and attributes:

  • A degree (BSc, MSc or PhD) in Toxicology or another appropriate scientific discipline.
  • Good toxicology project management skills with experience gained in the pharmaceutical industry or contract research organisation (CRO) environment
  • Knowledge of safety pharmacology and abuse liability studies would be an advantage.
  • Experience in drafting submissions to FDA would be an advantage.
  • General knowledge of the pharmaceutical drug development process desirable.
  • Knowledge of regulatory guidelines and legislation.
  • Experienced in scientific writing
  • Good organisational skills and the ability to prioritise and problem solve
  • Ability to lead, direct, manage, motivate and develop individuals and third parties.
  • Good report writing and presentation skills
  • Good communication skills
  • Excellent attention to detail
  • Working knowledge of Excel, Word, Powerpoint, Endnote, search engines and databases used for literature searches.
  • Ability to work in a team and as an individual
  • Demonstrates a pragmatic approach to problem solving
  • Self-motivated approach, with a willingness to assist colleagues to achieve goals. 

Location: Cambridge

 

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

ADME Pharmacology Project Manager

 

Permanent

 

The Role

Will primarily entail the design, management and reporting of ADME and pharmacology studies to GLP regulations and company SOPs. Excellent writing skills are required for contribution to technical sections in regulatory submissions such as Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), New Drug Application The successful candidate will also participate in Product Development Plans for pipeline compounds.

 

Duties

  • Design, set up, conduct, tracking and reporting of ADME and pharmacology studies.
  • Ensure that the internal and external stakeholders (e.g. GW staff, researchers or Development Partner personnel) are fully informed of study requirements and progress.
  • Ensure that appropriate documentation is in place for the set up and conduct of GW studies.
  • Preclinical study design and protocol development.
  • Evaluation and selection of CROs, placement and management of studies.
  • Monitor conduct of studies, and participate in the interpretation of study results and finalisation of the final study report.
  • Assist in forecasting and tracking of time lines and budgets
  • Manage the material requirements for the GW pharmacology programmes to ensure that materials are always available as appropriate.
  • Manage bioanalytical methodology to support the preclinical programme
  • Ensure that GLP preclinical studies are run in accordance with the appropriate GW SOPs and relevant regulatory guidelines and legislation.
  • Ensure that non-regulated preclinical studies are run in accordance with the appropriate GW SOPs and relevant regulatory guidelines and legislation.
  • Contribute towards the maintenance of the preclinical departmental SOPs
  • Participate in GW Product Development Plans.
  • Prepare relevant sections of documents for regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), New Drug Application (NDA) market Authorisation Application (MAA) and Investigator Brochures (IB).
  • Contributes to update of GW Data Packages.
  • Participate in appropriate therapeutic area training to educate the preclinical team and other GW departments in ADME and pharmacology.

The successful candidate will have the following skills and attributes:

  • A degree or higher degree (Bsc, MSc or PhD) in Pharmacology or another appropriate scientific discipline.
  • Knowledge of appropriate regulatory guidelines and legislation.
  • Working knowledge of ADME studies desirable.
  • General knowledge of the pharmaceutical drug development process desirable.
  • Experience in a pharmaceutical company or CRO in a nonclinical / preclinical discipline, preferably in an ADME role.
  • Experienced in scientific writing
  • Experienced in presenting key data at national and international meetings and symposia.
  • General understanding of budgetary control
  • Good organisational skills and the ability to prioritise
  • Ability to use initiative and problem solve
  • Ability to lead, direct, manage, motivate and develop individuals and third parties.
  • Good report writing and presentation skills
  • Good communication skills
  • Excellent attention to detail
  • Working knowledge of Excel, Word, Powerpoint, Endnote, search engines and databases used for literature searches.
  • Ability to work in a team and as an individual
  • Demonstrates a pragmatic approach to problem solving
  • Self-motivated approach, with a willingness to assist colleagues to achieve goals.

 

Location: Cambridge

 

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

 

Program Scheduler

 

Permanent

 

The Role

To facilitate Project Planning throughout the project to ensure an optimum schedule is maintained.

 

Key Responsibilities

  • Facilitate generation of new project plans
  • To maintain all live plans through periodic review and update from Project Leaders
  • Gather progress information from Project Team members to allow progress to be monitored, and highlight issues/delays to the Program Leads.
  • Ensure all planning changes are clearly documented and recorded.
  • Provide performance measurement.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.

Essential Skills

  • Proven ability to apply sound logic when translating information into a logical sequence of events which require fully linked dependencies
  • Good organisational skills, including the ability to organise the work of a team to meet agreed deadlines; ability to work independently or as part of a team, to agreed deadlines
  • Strong analytical and reporting skills
  • Excellent computer literate in Microsoft packages especially MS Project, Project Server (EPM) to plan timelines and track resource time against tasks.
  • Experience in producing reports for presentation to management through MS Project, Excel and Powerpoint.

 

Location: South East 

 

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

Clinical Research Associate – US (various locations)

 

Fixed Term Contract

 

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 drive 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 and expenses claims in a timely manner to an acceptable quality. 

 

Locations: Boston and surrounding Massachusetts or Connecticut, Mid-West – Illinois/Minnesota/Ohio, South East – Georgia/Florida/North Carolina/South Carolina; New York/New Jersey.

 

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

 

Regulatory Project Manager

 

Permanent

 

The Role

Oversees the preparation of Marketing Authorisation Applications (MAAs), variations and Product Information and manages the Regulatory interaction with all Marketing Partners. Responsible for all Regulatory maintenance activities. The job holder will manage a small Regulatory team.

 

Key Responsibilities

  • Leads team undertaking maintenance activities.
  • Ensures all Marketing Authorisation Applications (MAAs) and maintenance activities are successfully undertaken.
  • Ensure all MAs for which Marketing Partners are MA holders are successfully supported.
  • Oversees preparation of global commercial Regulatory Text / Artwork for SPC /Patient Leaflets and labels and approval of commercial texts.
  • Ensures that activities under their control are carried out in ways to minimise risks to health, safety, security and the environment.
  • Oversees the preparation of Marketing Authorisation Applications (MAAs), variations and Product Information.
  • Responsible for all Regulatory maintenance activities.
  • Manages the Regulatory interaction with all Marketing Partners.
  • Manages a small Regulatory team.

 

Essential Skills

Knowledge:

  • Degree in life sciences.

Experience:

  • Planning of all Regulatory maintenance activities
  • Preparation and submission of MAAs and variations.
  • Preparation and control of Product Information.
  • Proven experience in the commercial pharmaceutical environment.
  • People Management 

Skills:

  • Ability to lead, direct, manage and develop others
  • Good organisational and prioritisation skills.
  • Good communication skills.
  • IT competency - Excel / Word / Power-Point.
  • Excellent attention to detail.
  • Project Management.

 

Location: South East 

 

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

Clinical Research Associate – Northern England/Scotland

 

Fixed Term 12 Months

 

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 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.
  • Knowledge of relevant GW SOP’s, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and applicable regulatory guidelines.
  • Ability to drive and be available for extensive travel including overnight stays, as required.
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail.
  • 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.

 

Location: Northern England/Scotland

 

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

 

Quality Assurance Executive (QAE) Devices

 

9 Month Contract

 

The Role

To assist the Quality Assurance Manager and other QA team members in implementation of the Quality System for our company and associated contractor sites.

Develop, implement and maintain Quality Assurance programs on assigned areas in Manufacturing, Supplier Management, Process Validation and New Product Introduction.

To work with all necessary departments to ensure the GMP, ISO and FDA QA system are current and in compliance with the current guidelines.

To review and work to continuously improve compliance within our company through promoting QA and developing sustainable quality systems as directed by the quality management team.

To assist in the development QA staff members, training and mentoring as required.

 

Key Responsibilities

  • Responsible for maintaining cGxP and EHS knowledge applicable to the job.
  • Review the Quality Management System and recommend all necessary updates to ensure compliance with 21 CFR part 4 and 803, ensuring that the proposed changes do not adversely affect compliance with other European or US requirements.
  • Implement the proposed QMS changes including training of all relevant staff.
  • Reviewing of device validation documentation, ensuring they are clear, complete and in compliance with company procedures, regulatory requirements, marketing partner requirements and GMP/ISO requirements. To achieve agreed average review times.
  • Day to day training, mentoring and development of members of the department to pass on practical knowledge and experience in device QA systems.
  • Support the regular review and development of the Quality Systems within the area of specialism as required by ICH Q10 to ensure the systems and procedures are compliant with cGMP standards.
  • Monitoring and continuously improving quality metrics (KPI) pertinent to devices. Assisting in the achievement of acceptable levels of performance through training, regular area visits and influencing others in all departments on site.
  • Assist or lead audits (external and internal) as required to assess or qualify suppliers supporting the audit programme.
  • Monitoring, assessing and auditing of device component suppliers working with GW site quality management
  • To ensure they understand the health, safety, security and environmental protection in their departments and the areas they visit as part of their role.

 

Essential Skills

Knowledge:

  • Education to degree standard, in a scientific, engineering, or quality systems discipline or,  experience from vocational training
  • Knowledge of device legislation within EU and USA specifically FDA 21 CFR part 4 and 803.

 

Experience:

  • Experience working in an EU and FDA regulated pharmaceutical environment in a quality role is essential. Experience in an IMP/new product development role would be beneficial.
  • Demonstrable experience of working with a variety of quality management systems including PQR, change control, CAPA, technical investigations (complaints, OOS, deviations, failure investigations, etc) and auditing (external and internal).
  • Experience of developing and sustaining QMS systems for devices linking to GMP would be essential.
  • Experience of preparing for regulatory audits or presenting to MHRA, FDA.
  • Experience in using root cause analysis or problem solving tools including statistical process controls.
  • Experience in running or assisting in quality risk assessment

 

Location: South East 

 

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

 

Clinical Trial Supplies Programme Manager

 

Fixed Term contract

 

The Role

Reporting into the CTS Study Management Team Lead, the successful candidate will support the planning and management of a range of activities to support clinical trial supply to world-wide destinations and agreed timelines, ensuring clinical study requirements are met. The job-holder will have responsibilities for documentation, protocol planning, clinical labelling, forecasting and study demand management, packaging, storage and despatch. This position requires a high level of customer and physician contact and co-ordination globally.

 

Key Responsibilities

As a Clinical Trial Supplies Programme Manager you will also coordinate all project related documentation while supporting the activities of internal operational departments and external vendors. There is a requirement for assisting with remote Depot management and a degree of site management will be required in terms of liaising with site contacts to ensure continuity of supply.

The nature of the position requires the successful job-holder to work alongside a range of internal and external stakeholders including suppliers, partners, depots, distributors, Regulatory and Legislative Authorities. Excellent report writing and communication skills are required.

 

Essential Skills

This responsible position would be suitable for an experienced Pharmaceutical / Clinical Trial supply professional who can take a hands-on approach to co-ordinating the daily product supply activities. Previous experiences that are desirable include aspects of pharmaceutical / clinical trial packaging / labelling / storage / distribution / planning / materials control and IVR (Interactive Voice Response) systems.

Experience of clinical trial supplies is essential, along with excellent organisation, planning and project management, communication, and inter-personnel skills.

 

Location: South East 

 

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

 

Medical Director

 

Permanent

 

The Role

This individual will be responsible for ensuring the global medical integrity of the cannabinoid development program, and shaping and developing the global medical affairs strategy to support one or more GW products that are currently in clinical development and which GW intends to market in the US and ROW. 

 

As such the role can perhaps be best thought of as a ‘hybrid’ one working across R&D and Medical Affairs from both an operational and geographical perspective, with the focus evolving over time.

 

Key Responsibilities

Developing constructive working relationships with external stakeholders including key opinion leaders, principal investigators, patient advocacy groups, and may include regulatory interactions. Internally, key working relationships will be global marketing, US medical affairs, clinical research, and regulatory affairs

 

Essential skills:

  • Broad skill set in Medical Affairs, clinical development, Drug safety and regulatory affairs
  • Strong customer orientation, science based and marketing minded, negotiation skills
  • Operational excellence, Management skills, planning, prioritization, decision making, objective setting, meeting management and plan execution
  • Medical Education (MD);  clinical development and medical affairs.
  • Experience within pharmaceutical or biotech,
  • Knowledge of Pharmaceutical product development, product lifecycle and commercialisation process with advanced understanding of other functions including Clinical Operations, Commercial, regulatory, safety,  medical and market access.
  • Statistical analysis
  • Solid understanding of research study design and relevant development guidelines
  • Medical affairs experience across one or more EU country
  • Neurology specialist experience
  • Strong business acume

 

Desirable skills:

  • Epilepsy experience
  • ABPI code of practice certified
  • Pharmaceutical affiliate and global experience
  • Knowledge of pharmaceutical regulations and pharmacoeconomics
  • Working in cross-functional teams in a matrix environment
  • Finance/budgeting and resource management experience
  • Leadership experience

 

Location: Cambridge

 

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

Deputy CRA Manager required in USA (Field Based)

 

FTC 12 months

 

The Role

  • To provide CRA resource for clinical trials from trial set up to database lock.
  • Line management and performance responsibility for assigned contract and freelance CRAs.

 

Key Responsibilities

  • Line management and supervision of assigned contract and freelance CRAs in mainland Europe.
  • Manage assigned CRA performance and identify training requirements to ensure clinical studies are reported within timelines and budgets.
  • Ensure CRAs have knowledge and understanding of all necessary procedures and regulations.
  • Report to CRA Manager/Clinical Operations Director/Senior Management on performance of assigned CRA team.
  • Input into clinical department SOPs/processes
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Essential Skills

  • Bachelor’s degree (BSc.) or equivalent in life science or allied health fields such as nursing, pharmacy or health science.
  • Experience in the pharmaceutical industry with senior CRA experience.
  • Ability to recruit appropriate personnel with required skills and knowledge.
  • Experience of line management
  • Has understanding of the regulatory process, including how this interacts with the clinical activities and processes, including safety reporting.
  • Knowledge of processes required of line managers.
  • Have a very high degree of accuracy and attention to detail with a proven track record for ensuring quality data.
  • Have strong leadership and negotiation skills.
  • Possess excellent verbal and written communication, interpersonal and organisational skills.
  • Flexible and adaptive approach to work.
  • Has developed understanding and increases knowledge of medical terminology common to therapeutic area(s).
  • Has good working knowledge of relevant GW SOP’s, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and applicable regulatory guidelines.
  • Demonstrates and applies an understanding of the purpose of monitoring, including interpretation of the Declaration of Helsinki and the principles of Good Clinical Practice.
  • Ability to drive and be available for extensive travel including overnight stays, both domestically and internationally, as required.

 

Desirable Skills

  • Fluency in languages other than English
  • Previous experience in core GW therapeutic areas and/or studies using controlled medications
  • Competent with standard and job specific computer applications including Microsoft Office, SharePoint and Electronic Data Capture systems
  • Previous experience with risk-based monitoring approaches

 

Location:  Field-based, US. This role will involve travel throughout the United States of America

 

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

 

 

Commercial Contract Manufacturing Manager

 

GW is an expanding pharmaceutical company and we are looking for a Commercial Contract Manufacturing Manager to join our Manufacturing Operations group based in South East England.

 

The role is a key position within the company requiring management of commercial operations with our external contract manufacturers and suppliers.

You will also manage the outsourcing of activities associated with API Manufacture and Drug Product operations from both a Technical and Commercial perspective.

 

Reporting in to the Site Director you will be need to:

Deliver external manufacturing plans on time and in full to the quality specified in the technical agreements and on budgeted cost of goods.

Manage approved budget and expenses for external manufacturing operations. To manage the commercial contracts

Ensure outsourcing and contract manufacturers are fully compliant with cGxP and support internal and external audits. Ensure facilities are ready to support regulatory inspections (FDA and MHRA)

Ensure contract companies meet the necessary standards and company policy requirements for Environmental, Health & Safety

Develop Operational Excellence initiatives and adopt best practices to make productivity and cost of goods improvements with external suppliers

To work with suppliers to develop Key Performance Metrics  

To act as the main point of contact between external partners and site functional groups. To ensure good and timely communication with all functional areas and management

To help manage change controls, alerts, deviations, complaints, OOS and ensure these are executed and closed out in a timely manner. To ensure we have a Quality and or a Technical Agreement in place with all our external suppliers and ensure compliance with the requirements.

To oversee troubleshooting and resolution of product quality and technical problems with external contract suppliers.

 

 Knowledge, Skills and Experience Required:

A background in Manufacturing or Supply Chain is essential.

A science or engineering background would be preferable, qualification to degree standard would be an advantage

Will have a demonstrated track record with relevant experience working in a regulated industry.

Proven Commercial Operations experience.

  

This is a full time, permanent position, based in South East England.

 

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.