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.

Clinical Research Associate – Northern England & Midlands, UK

 

Fixed Term 12 Month 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 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 travel to sites 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/Midlands, UK

 

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

 

Regulatory Project Manager – US

 

Permanent

 

The Role

To manage 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
  • Regulatory submissions and project management experience
  • Shares ideas and information, seeks out collaboration and advice as needed
  • Knowledge of FDA and ICH guidelines and up to date training on SOPs
  • Organizational and time management skills
  • Self-starter and problem solver
  • Able to work as a team and as an individual
  • Good communication skills and customer service oriented
  • Excellent attention to detail
  • Adaptable and flexible

 

Desirable

  • Involvement in regulatory strategy and decision-making
  • Involvement in project and program management
  • Additional higher educational qualification, such as a Master’s degree or PhD. 

 

Location:  North Carolina, US 

 

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

Quality Control Scientist/Analyst/Technician - UK

 

12 Month Fixed Term Contract

 

The Role

The role entails the analysis of pharmaceutical raw 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 Scientist, Analyst or Technician level.

 

Key Responsibilities

  • Chemical and physical analysis of raw 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, UK 

 

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

 

Clinical Pharmacologist – Cambridge, UK

 

Permanent

 

The Role

Responsible for providing Clinical Pharmacology support along with absorption, distribution, metabolism and excretion (ADME) input and scientific opinion to project teams, line management, and governance bodies.

The Clinical Pharmacologist serves as the Clinical Pharmacology expert on program teams and execution of clinical pharmacology plans that characterise the ADME and PK/PD of the drug candidate, providing rationale for dose regimen selection and identifying circumstances where dose adjustment should be considered.

The position will also be a resource to teams for guidance on all matters related to Clinical Pharmacology and Pharmacokinetics, Pharmacodynamics and Drug Metabolism.

 

Key Responsibilities

  • Provides strategic Clinical Pharmacology support and guidance to clinical stage project teams, enabling the team to achieve the optimal product profile for initial and lifecycle formulations and indications.
  • Provides clinical pharmacology study expertise (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, and reporting) within assigned programs to yield high value PK/PD insight for future critical decisions. Analyses results, interprets, and recommends action based on study results.
  • Collaborates with Clinicians, Clinical Science Group and Clinical Operations at GW to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
  • Identifies and efficiently resolves programme and study-specific issues.
  • Works with study and programme teams to achieve programme goals and provides deliverables in approved timeframes.
  • Responsible for the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data internally and in collaboration with external vendors/academic sites
  • Works closely with the Clinicians, Clinical Science Group and Clinical Operations group to understand analytic methods, method validations, project plans, and data reports in support of concentration data for their programs.
  • Lead and prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports, NDA/MAAs with respect to Clinical Pharmacology studies or data.
  • Work with pre-clinical colleagues to understand relationship between clinical data and preclinical findings.

 

Essential Skills

  • BSc. or Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with a thorough understanding of the biopharmaceutical industry.
  • Strong knowledge of pharmacokinetics and modeling, pharmacodynamic principles, ADME concepts, bioanalytical principles and strategic integration of these data needed to support successful NDA/MAA filing and registration.
  • Proficient in standard MS software (Word, Excel and Power Point) and experience using WinNonlin or other pharmacokinetic software.
  • Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal skills and ability to function in a team environment are essential. Travel may occasionally be required.
  • Advanced ability to successfully manage a full workload across multiple-projects.
  • The candidate should be detail-oriented, a self-starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
  • Thorough knowledge of Food and Drug Administration (FDA) and European regulations.
  • Professional, proactive demeanor.

 

Desirable

  • Previous experience of working with epilepsy studies would be an advantage

 

Location: Cambridge, UK

 

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

 

Associate Clinical Project Manager - US Field based

 

12 Month Fixed Term Contract

 

The Role

To be responsible for the timely start-up and maintenance of all U.S. sites for five clinical trials in Epilepsy, according to ICH/GCP guidelines and regional regulations.

 

Key Responsibilities

  • Management of start-up activities from site identification to site activation. To include overseeing site activities and documentation to ensure compliance with all regulatory requirements and GW SOPs.
  • To accelerate site activation through oversight and follow-through of all open site action items and tasks.
  • To participate in the evaluation and selection of investigational sites.
  • Oversight of monitoring at US sites, resolution of issues with CRAs and escalation of issues as required to CPMs/COL/COM.

 

Essential Skills

  • Broad Clinical Trial experience.
  • Knowledge of relevant SOP’s, ICH/GCP and regulatory guidelines.
  • Organizational skills and prioritization.
  • Ability to use initiative and problem solve.
  • Able to work as a team and as an individual.
  • Good communication skills.
  • Excellent attention to detail.

 

Desirable

  • Preferably with CRA or Start-up Lead experience.

 

Location: US – Field based

 

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

 

Management Accountant - UK

 

Permanent

 

The Role

An exciting opportunity has become available for this growing company. The accounts team is looking for Management Accountant to be the face of Finance at the site. This role will be working closely with the Finance Manager and Senior Managers of the company.

 

Key Responsibilities

  • Approving of Invoices
  • Stock Accounting including Cost of Sales calculations and variances
  • KPI’s
  • In Market Sales
  • Raising Sales Invoices
  • Reforecasting for the departments at site including liaising with Senior Managers about expected spend
  • Fixed Asset Accounting
  • Frequent travel to our other sites required
  • Adhoc Project Work
  • Assisting the accounts team with adhoc tasks 

Essential Skills

  • A Good understanding of excel is essential
  • 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
  • C or above in GCSE Maths and English
  • CIMA or Part CIMA Qualified
  • Previous Manufacturing experience essential 

Location:  South East - UK 

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

Principal Statistician - US or UK

 

12 Month fixed term contract

 

The Role

  • The Principal Statistician is a member of the clinical team and is responsible for statistical input, including SAS programming, to clinical studies. 
  • The Principal Statistician must ensure that activities and processes performed are conducted according to company requirements.  This position works closely with other team members.
  • Acts as primary statistical contact on complex trials and across multiple studies. 

 

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.
  • Provide valuable input into trial design and protocols.

 

Essential Skills

  • Masters in Statistics or a subject with a major statistical component with substantial relevant experience.
  • Extensive experience within the indication of epilepsy.
  • Experience of regulatory submissions within the indication of epilepsy.
  • Good knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
  • Proficient in the use of computers and especially the SAS system.
  • Ability to perform and interpret statistical analyses of clinical data.
  • Have a good understanding of clinical data, including data quality issues.
  • Able to work in a fast-paced, team-oriented environment.
  • Possess excellent interpersonal and communication skills (written and verbal).
  • Strong attention to detail with a view to bringing studies to a quality conclusion.
  • Flexible, positive, creative thinker, good communicator.
  • Able to work without close supervision.
  • Well-developed time management skills.  

Desirable

  • PhD in Statistics or a subject with a major statistical component.
  • Experience working on NDA submissions and interaction with the FDA 

 

Location: US – Field based East Coast or UK 

 

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

IT Support Analyst - UK

 

12 month fixed term contract

 

The Role

To provide support to all employees and help maintain IT systems.

A fantastic opportunity to join friendly and knowledgeable IT department in this fast moving and exciting company.

Training will be given and you will gain experience in Microsoft technologies including Lync, SharePoint and Systems Center.

 

Key Responsibilities

  • Technical support for Windows desktops and laptops to include 1st/ 2nd line
  • Logging calls using Service Manager
  • Support for corporate infrastructure and computer systems
  • User training and guidance on best practice
  • Change Control documentation
  • Project work

 

Essential Skills

  • Responsible for 1st/2nd line user support on all aspects of computer use including desktop software and hardware.
  • Logging calls using System Centre Service Manager 2012
  • To serve as a subject matter in areas of expertise and be knowledgeable in the line of work.
  • Manage my own time to effectively complete any support requests and orders for equipment in a timely manner.
  • Coach and educate users on best practices to ensure efficient use of systems.
  • Responds to telephone support calls in a professional manner.
  • Creation of detailed control documentation to a high standard.
  • Administration of Active Directory and Exchange.
  • Management of data backups

 

Location: Cambridge, UK

 

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

 

Pipeline Program Director - UK

 

The Role

The individual will be responsible for defining and leading GW’s pipeline management approach, and leading one or more drug development programs.  The role involves close working relationships with drug discovery and development, commercial and business development and legal affairs.  The principal deliverables are to govern an enduring pipeline of candidate products for in-house or out-licensed full development.

 

Key Responsibilities:

The Director will be responsible for:

  • Directing the transition of compounds from late discovery, through early clinical development (“Pipeline”), to point at which they are accepted as strategic programs with their own governance structures and leadership, or outlicensed.
  • This includes oversight of the development of these investigational products through relevant US and ex-US regulatory reviews and, where allocated, directly leading the drug development efforts.
  • Leading the cross-functional development teams that may include Drug Discovery, Technical Development, Clinical Operations, Regulatory Affairs, Safety-Pharmaco-vigilance, Commercial Operations, Business Development and Legal Affairs.
  • Responsible for implementing and augmenting existing program management to ensure an efficient approach to the planning and execution of ongoing programs and to guide the organisation in a systematic method to portfolio prioritisation.
  • Responsible for the overall health, safety, security and environmental protection in their department.

 

Essential Skills

  • B.Sc. minimum, Masters or Ph.D./M.D./Pharm.D. preferred.
  • Expert knowledge of scientific principles and concepts.
  • Strong understanding of clinical study design, including protocol writing, and ideally statistical design.
  • Program Management, Portfolio Management & Program Leadership
  • Strong understanding of the Regulatory Environment in both US and EU including IND/CTA and NDA/MAA strategy and process.
  • Awareness of US Compliance regulations on HCP interactions and promotion.
  • Knowledge of the requirements in clinical development that maximise market access in the commercial phase (i.e. understanding of pharmaco-economics in development).
  • Broad knowledge of ICH-GxP, EU and FDA requirements.
  • Knowledge of non-clinical drug development and drug manufacture processes a distinct advantage. 

Location: Cambridge, UK 

 

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

 

Clinical Research Associate – Texas, US

 

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 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: Texas, US

 

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

 

Clinical Research Associate – IMP returns specialist – US

 

Fixed term contract - 18 months

 

The Role

Responsible for supporting the existing US CRA team with the IMP accountability and returns process for ongoing and future clinical trials in accordance with GW SOPs, ICH-GCP, FDA CFR 21 and relevant local and international regulatory guidelines as applicable.

 

Key Responsibilities

  • Ensures the integrity of clinical data in relation to IMP documentation 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 pertaining to IMP accountability and return at :
    • monitoring visits
    • closeout visits
  • Collaborates with the US CRA and CPM teams to plan and schedule regular accountability and shipment of returns of a controlled IMP.
  • Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure compliance with applicable regulations and the protocol for IMP accountability and returns.
  • 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, 314 and 1308 and other regulatory guidelines, as applicable.
  • Previous experience of working with Schedule I and/or Schedule II controlled substances essential (Preferred).
  • Previous experience with shipping Dangerous Goods and current IATA Certification (Preferred).
  • Fluent in English.
  • 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 be available for domestic and international travel including overnight stays, as required.
  • Able to use initiative and problem solve.

 

Location: East Coast USA, but regular travel across the US will be required.

 

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

 

Archive Administrator – UK

 

18 month fixed term contract

 

The Role

To coordinate the collection of key essential documents, from the Clinical Trial Supplies Department (CTS), for the purpose of the Trial Master File (TMF) compilation and departmental archive. This role will maintain and manage the document archive within CTS and prepare key essential documentation for transfer to the company archivist.

 

Key Responsibilities

  • To identify and collate key essential documentation required for the TMF for the CTS department.
  • To maintain, where appropriate, the TMF content for current active GW clinical trials.
  • To review for completeness (according to the current document practice within CTS and the GW company retention procedure) all documents identified as part of the TMF.
  • Where anomalies are identified to ensure these are raised as a concern and followed through to completion.
  • To ensure that documents required to be retained and archived in more than one place are copied and managed appropriately to ensure clear visibility and location of original content.
  • To maintain the CTS document archive.
  • To work with external archiving vendors as appropriate to ensure clear visibility of the location of documents.
  • To contribute to the process of TMF and CTS archiving as part of any process improvements.  

 

Essential Skills

  • Archivist qualification is not essential however a good standard of education is desirable.
  • Attention to detail is essential within this role.
  • Good communication skills both written and verbal.
  • An understanding of document classification and indexing is desirable.
  • A good knowledge of archiving principles and accuracy.
  • Experience of working within a regulated environment.
  • A good knowledge of Excel and the use of spreadsheets.
  • High level of numeracy.

 

Location: South East, England 

 

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

 

Applications without a covering letter and salary requirements will not be considered.

Quality System Project Lead - UK

 

12 month fixed term contract

 

The Role

This role not only supports the Clinical QA team in managing the audit programme for all GW clinical studies and supporting the quality systems gap analysis and continual improvements programme for the teams involved in clinical studies, but also supports the quality systems improvements for the manufacture of active pharmaceutical ingredients and finished products for commercial, investigational and specials use in a rapidly growing operation across multiple markets. 

 

Key Responsibilities

  • To manage the project to upgrade the quality system to take the company forward as it expands.
  • Accountable for the delivery of the Quality System development project within the constraints of the agreed schedule and budget,
  • Ensures the effective performance of all team members under their control.
  • Responsible for maintaining cGxP knowledge applicable to the job.
  • Oversee the quality system upgrade project for clinical studies and support the manufacturing and development function where required for their systems’ upgrade programmes.
  • Provide support, advice, education and training to other departments.

 

Essential Skills

  • Proven management experience in an MHRA/FDA regulated environment and an excellent working knowledge of current ICH, EU and US regulatory requirements and their implementation.
  • Experience in a clinical environment would be advantageous as would be manufacturing experience with non-sterile dosage forms such as oral liquids and capsules, and/or natural products - particularly botanicals.
  • Ideally a Bioscience Degree Chemistry/Pharmacy qualification.
  • Experience of GxPs, especially GCP, cGMP and CSV.
  • Experience of working in a GxP or regulatory environment at management level.
  • A working knowledge of US FDA cGxP requirements would be advantageous.
  • Experience of successfully managing a team.
  • Able to travel to other sites as required.

Location: Cambridge - UK 

 

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

Pharmacology Project Manager

 

Permanent

 

The Role

The design, management and reporting of pharmacology studies to regulatory requirements and company SOPs. Contribution to technical sections in regulatory submissions such as Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), New Drug Application. Assisting with Product Development Plans for pipeline compounds.

 

Key responsibilities

  • Design, set up, conduct, tracking and reporting of pharmacology studies
  • 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 AROs and 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
  • Manage the material requirements for the GW pharmacology programmes to ensure that materials are always available as appropriate
  • 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. 

Required Skills

  • A degree or higher degree (Bsc, MSc or PhD) in Pharmacology or another appropriate scientific discipline
  • Experience in an academic setting, pharmaceutical company or CRO.
  • Knowledge of appropriate regulatory guidelines and legislation desirable
  • Knowledge of therapeutic areas such as oncology, inflammation, metabolic disorders or CNS disorders desirable
  • General knowledge of the pharmaceutical drug development process desirable
  • 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.
  • Excellent report writing and presentation skills
  • Excellent communication skills
  • Good 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 and notice period 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 

Deputy Computer Systems Validation Manager

 

12 month fixed term contract

 

The Role

To work with the CSV Manager in our informatics team to ensure computerised systems are in compliance with 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 GMP, GCP, GAMP, Annex 11 and FDA 21 CFR Part 11.
  • 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.

 

Location: South East 

 

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

 

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 travel to sites 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

 

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

 

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.