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.

 

Analytical Development (Stability)

 

Permanent

 

The Role

Test and report on stability protocol time-points according to the relevant test methods, SOPs and protocols, under the direction of the Stability Laboratory Manager and/or Head of Analytical R&D.

 

Key Responsibilities

  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job
  • Perform all duties in accordance with safe working practices and where applicable GMP
  • Provide clear and accurate records of all work performed
  • Notify the Laboratory Manager and/or the Head of Analytical R&D of any OOS results
  • Enter data into the appropriate records
  • Report promptly any problems occurring at any phase of a study to the Laboratory Manager and/or the Head of Analytical R&D
  • Ensure all equipment is fully calibrated and serviced in accordance with company procedures
  • Maintain all areas of the laboratory in a clean and tidy state
  • Work independently but readily provide support, training or coaching to other team members
  • Ensure Compliance Wire Core SOPS are read
  • Ensure any other relevant SOPs and Test methods have been read
  • Ensure training records are kept up to date
  • Carry out any other duties as required by the management

 

Essential Skills

Knowledge/Experience:

  • Scientific based degree and laboratory experience
  • Extensive practical experience with HPLC
  • Previous experience with Dissolution Testing
  • Previous experience of QC or Stability Analysis
  • Previous experience of working in a GMP environment

 

Skills:

  • Competent in the use of general laboratory instrumentation and devices e.g. pipettes, balances etc.
  • Working knowledge of Excel and Word
  • Excellent attention to detail - the job role requires checking of analytical data, reviewing of SOP’s, Test Methods, Protocols and Reports
  • Communication skills including written and verbal - the job role requires writing of various analytical documents including Test methods, SOPs and protocols

 

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

 

CTS Material Coordinator

 

Fixed Term contract

 

The Role

Reporting into the CTS Material Coordination Team Lead, the successful candidate(s) will support the material management, packaging and labelling activities to support clinical trial supply to world-wide destinations and agreed timelines, ensuring clinical study requirements are met.

 

Key Responsibilities

The job-holder will have responsibilities for documentation, packaging and labelling in a GMP environment, the management of returned material, providing input in to the departmental schedule, storage and despatch.

 

Essential Skills

This hands-on position requires a high level of flexibility and a can do attitude.

 

As a Clinical Trial Supplies Material Coordinator you may also be expected to liaise with external vendor for the management of components and sundries

The nature of the position requires the successful job-holder to work within a team of Material Coordinators and so a people orientated person with a positive disposition who can interact confidently with a range of internal and external stakeholder would be desirable.

There may be opportunities to input in to process development and so a good level of written English is required.

 

Location: South East 

 

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

 

Clinical Trial Supplies Co-ordinator

 

Fixed Term contract

 

The Role

Reporting into the CTS Operations Team Lead, the successful candidate will work in partnership with the CTS Scheduler and Programme Manager in the preparation and execution of the clinical group study requirements to agreed timelines, ensuring clinical study requirements are met.

 

Key Responsibilities

The job-holder will be responsible on a day to day basis for assigned study supply preparation and documentation to support the packaging and labelling activities. This includes the full lifecycle of clinical trial material from packed, labelled and released to returns and accountability from clinical study sites.

This position requires a high level of focus on detail and translating clinical protocol requirements through the Programme Manager to actual deliverable clinical trial units fit for patients. The applicant is expected to be able to be highly organised and work in accordance with company standard operating procedures ICH guidelines and agreed timelines. 

It is expected that there will be a high level of external and internal communication so ability to highlight competing priorities is a must.

Throughout the department here is also a strong emphasis on process improvements and opportunities for collaborative continuous improvement projects.

 

Essential Skills

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.

This responsible position would be suitable for an experienced clinical trial pack and label professional.

Previous experiences that are essential include aspects of pharmaceutical / GMP / clinical trial packaging / labelling / storage / distribution / planning / materials control and IVR (Interactive Voice Response) systems.

Experience of clinical trial supply design is essential, along with excellent organisation and communication skills.

 

Location: South East 

 

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

 

Documentation Control Officer – Quality Department

 

Permanent

  

Role

This person will control the administration of documents required for the manufacture of pharmaceutical products.

 The ideal candidate will have an organised approach to document control with the ability to prioritise workload, be proactive and be able to work under pressure especially in audit situations. 

 

Responsibilities:

Responsibilities include issuing and maintaining version controlled documentation, such as Standard Operating Procedures (SOPs), Batch Manufacturing Records, Forms, and other records.  Authoring/updating appropriate GMP and Quality System related documents i.e. SOP’s, Forms when required.  Controlling the document archive, ensuring that documents are archived correctly.  Controlling timely routine reviews of documents.

 

Skills Required:

Good communication and interpersonal skills are required, as well as the ability to finish tasks, and computer literacy in MS Office and Adobe Acrobat.  The position offered is part of the Quality function within the company, so attention to detail and compliance with procedures is essential. 

 

This position reports to the Senior Document Control Officer, working in conjunction with the Document Control Assistants, and is an excellent opportunity for those wishing to improve their knowledge of Quality Systems and be part of continuous improvement within Document Control. 

 

Essential Experience:

  • Proficient computer and IT skills including; Word, Excel and experience of use spreadsheets.
  • Good communication and interpersonal skills to liaise with all departments on site.
  • Experience of working as part of a team and on a one to one basis. 

 

Desirable Experience:

  • Administration skills within SharePoint system.
  • Previous experience in Document Control.
  • A knowledge and understanding of Good Manufacturing Practice or Quality Systems such as ISO9000, and/or qualifications in a science-based discipline would be an advantage. 

Location: South East 

 

In the first instance please email your CV with salary details to recruitment@gwpharm.com    

Clinical Research Associate – West Coast US

 

12 month 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 and 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. 

 

Location: West Coast US

 

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

 

Clinical Research Associate x 2 (One Midlands based/One National)

 

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 and 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: One role based in the Midlands.  The other role is National.

 

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

 

Clinical Research Associate – UK (London/South East)

 

Permanent

 

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 and 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: South East 

 

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

 

Clinical Project Manager

 

FTC – 12 months

 

The Role

To be responsible for the execution of Phase I-IV and other approved clinical studies according to ICH/GCP guidelines and regional regulations.  Overall management of sponsored clinical trials from study design to clinical report finalisation, ensuring that the studies are conducted to the highest quality standards, are within the agreed budget and are delivered on time.

 

Key Responsibilities

  • Management of sponsored clinical trials in various therapeutic areas as determined by the needs of the organisation. Primarily focusing on Phase 1 clinical studies.  To include writing documents (i.e., protocols, and specific project plans), overseeing monitoring to ensure compliance with all regulatory requirements for the study, and evaluating and selecting study investigators.
  • To participate in the selection of all vendors for the responsible study and their supervision as required. 
  • To participate in Investigator Meetings and training of cross-functional team members. 
  • To manage timelines from project concept to delivery of the Clinical Study Report.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job

 

Essential Skills

  • Broad Clinical Trial experience. 
  • A global view of drug development. 
  • Ability to lead, direct, manage and develop others. 
  • Knowledge of relevant SOP’s, ICH/GCP and regulatory guidelines. 
  • General understanding of budgetary control. 
  • Organisation skills and prioritisation
  • Able to use initiative and problem solve
  • Able to work in a team and as an individual
  • Good communication skills.
  • Full driving license. 
  • Able to travel
  • Preferably with experience of clinical project management responsibilities and previous CRA duties

 

Location: Cambridge

 

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

Quality Assurance Executive - Horticulture

 

Permanent

 

The Role

  • To assist in the implementation of the Quality System
  • To work with all necessary departments to ensure the GMP and the GACP system is current and in compliance with the current guidelines and company filings.
  • To review and work to continuously improve compliance
  • To assist in the development QA staff members, training and mentoring as required

Key Responsibilities

  • Develop the quality management framework
  • Reviewing of batch records or, validation documentation
  • Leading and assisting in departmental investigations
  • Day to day training, mentoring and supporting of more junior members of the department.
  • Support the regular review and development of the Quality Systems within the area of specialism.
  • Monitoring and continuously improving quality metrics.
  • Assist or lead audits (external and internal) as required
  • Monitoring and auditing of contract manufacturing organisations (CMO’s)

Essential Skills

  • Experience working in an EU regulated pharmaceutical manufacturing site in a quality role is essential. Experience in an IMP or API regulated environment would be beneficial.
  • Experience of working in horticulture with a quality systems focus or a quality assurance background with some interest in horticulture would be advantageous.
  • Experience in working within a contract manufacturing environment.
  • Demonstrable experience of working with a variety of quality management systems including change control, technical investigations (complaints, OOS, deviations, failure investigations, etc) and auditing (external and internal).
  • Experience of developing and sustaining QMS systems would be beneficial.
  • 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

Quality Assurance Executive IMP

 

Permanent

 

The Role

  • To assist the Quality Assurance Manager and other QA team members in implementation of the Quality System.
  • To work with all necessary departments to ensure the GMP and the GACP system is current and in compliance with the current guidelines and company filings.
  • To review and work to continuously improve compliance through promoting QA and developing sustainable quality systems as directed by Senior Quality Assurance Executives (SQAE) and quality management team.
  • To assist in the development QA staff members, training and mentoring as required.

 

Key Responsibilities

  • The job holder is responsible for maintaining cGxP and EHS knowledge applicable to the job.
  • Reviewing of batch records or, validation documentation.
  • Leading and assisting in departmental investigations including Deviations, OOS, OOE, OOT and complaints.
  • Day to day training, mentoring and supporting of more junior members of the department.
  • Support the regular review and development of the Quality Systems within the area of specialism as required by ICH Q10.
  • Monitoring and continuously improving quality metrics (KPI) pertinent to area of specialism.
  • Assist or lead audits (external and internal) as required supporting the KSP audit programme.
  • Monitoring and auditing of Contract manufacturing organisations (CMO’s) working with GW site quality management.

 

Essential Skills

Knowledge:

  • Education to degree standard, in a scientific or quality systems discipline or experience from vocational training.

 

Experience:

  • Experience of working in an EU regulated pharmaceutical manufacturing site in a quality role is essential. Experience in an IMP or API regulated environment would be beneficial.
  • Demonstrable experience of working with a variety of quality management systems including PQR, change control, technical investigations (complaints, OOS, deviations, failure investigations, etc) and auditing (external and internal).
  • Experience of developing and sustaining QMS systems would be beneficial.
  • 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

 

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

Toxicology Project Manager

 

Permanent

 

The Role

We are seeking an experienced, motivated and talented individual, working within our preclinical team. The role will primarily entail the design, management and reporting of toxicology and safety pharmacology studies to GLP regulations and company SOPs’.

 

Key Responsibilities

  • Design, set up, conduct, tracking and reporting of toxicology and safety pharmacology 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.
  • Manage appropriate bioanalytical methodologies and long term stability studies  to support the preclinical programme
  • Ensure good laboratory practice (GLP) compliance in accordance with 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.
  • Participate in GW Product Development Plans.
  • Prepare relevant technical sections of documents for regulatory submissions, including Investigational New Drug (IND) applications, Common Technical Documents (CTDs) and Investigator Brochures.

 

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 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
  • Ability to lead, direct, manage, motivate and develop individuals and third parties.
  • Good report writing and presentation skills

Location: Cambridge

 

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

Global Head of Regulatory Affairs

 

Permanent

 

The Role

Direction and management of regulatory aspects of our products, information and activities globally.

 

Key Responsibilities

  • Participating in Strategic Management meetings to formulate regulatory strategy and to provide guidance for the data necessary for global development and marketing authorisation activities.
  • Liaising with Health Authorities and leading Health Authority interactions as required.
  • Development of the Regulatory team.
  • Directing the compilation of Marketing Authorisation Applications (MAA)s and New Drug Applications (NDA)s in liaison with GW staff, Commercial partners and external consultants.
  • Directing the preparation of Clinical Trial Applications (CTA)s and Investigational New Drug (IND) submissions.
  • The job holder is responsible for the overall health, safety, security and environmental protection in their departments.

 

Essential Skills

Knowledge:

  • Life Sciences degree.

 

Experience:

  • Extensive experience in Regulatory Affairs.
  • Regulatory experience to include Europe and USA.
  • Senior Management Team and Line Management experience

 

Location: London

 

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

By close of Business 18th December 2014.

 

Director of Regulatory Affairs (Cambridge-Clinical)

 

Permanent

 

The Role

The job holder manages regulatory aspects of our products, information and activities worldwide, with particular emphasis on clinical and nonclinical activities.

 

Key Responsibilities

  • Developing the regulatory strategy for all of GW’s development projects and to advise on any risks and mitigation of those risks, to development timelines.
  • Participating in key meetings as necessary in relation to the regulatory strategy and to provide guidance for the data necessary for Marketing Authorisation Applications (MAAs), Clinical Trial Authorisations (CTAs), Investigational New Drug (IND) dossiers and New Drug Applications (NDAs).
  • Liaising with Health Authorities and leading Health Authority interactions as required.
  • Development of the Regulatory team in Cambridge.
  • Overseeing all clinical submissions to Health Authorities.
  • Liaising with the Pharmacovigilance team in ensuring safety-related documentation is maintained.
  • Maintaining cGxP and H&S knowledge applicable to the job. 

Essential Skills

Knowledge:

  • Life Sciences degree.

 

Experience:

  • Extensive experience in Regulatory Affairs.
  • Regulatory experience to include Europe and USA.
  • Senior Management Experience

Skills:

  • Proven organisational skills, particularly when time constrained.
  • Creative yet attention to detail and regulatory guidance.

 

Location: Cambridge

 

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

By close of business 21st December 2014.

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

By close of business 8th December 2014

 

Deputy CRA Manager

 

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: Cambridge or Field-based, UK. This role will involve travel throughout the UK and Europe

 

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

By close of business 8th December 2014

 

IT Compliance Specialist

 

Permanent

 

An excellent opportunity has 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.

 

The Role

Reporting to the Head of IT, you will be responsible for providing lead support for IT and CSV compliance activities at the Cambridge office. You will write and execute change and error management, compliance and validation documents and Standard Operating Procedures (SOPs) and develop process improvements to maintain an effective compliant IT group.

 

With a proven background in IT compliance, you will provide technical input into change and installation documents, often involved in the required steps to implement them.

 

Key Responsibilities

The successful Applicant will be responsible for:

  • Writing new and developing existing Standard Operating Procedures (SOPs) and guidelines
  • Preparing responses and identifying remedies to issues arising from internal and external audits, risk assessments and testing
  • Providing lead IT and compliance support for the ARISg System (Pharmacovigilance Database)
  • Evaluating the effectiveness of IT processes, records and written procedures and implementing change to improve their performance
  • Producing and maintaining recordsConsulting computer users to ascertain needs and to ensure that facilities meet user and project requirements
  • Providing users with appropriate support and advice
  • Keeping up to date with the latest technologies and regulations
  • Interfacing with IT users/contractors/developers and suppliers
  • Project based work to continually improve the companies effectiveness.

 

Essential Skills

  • Broad understanding and working knowledge of the application of pharmaceutical & financial regulations to IT including GCP, GMP, GAMP, FDA 21 CFR Part 11 and SOX.
  • Pharmaceutical industry experience, including relevant experience in a role directly associated with pharmaceutical computer systems validation/qualification practices.
  • Highly computer literate with experience of the system design lifecycle, and development of qualification documentation in a regulated environment.
  • Experience of interfacing with IT users/contractors/developers and/or suppliers.
  • Project management.
  • First rate technical writing abilities.
  • Excellent analytical and problem solving skills.
  • Can manage crisis situations, which may involve complex technical hardware or software problems.

Ideally, you will be familiar with:

  • ARISg (version 6.3) Drug Safety Database or similar
  • Microsoft Windows Desktop
  • Microsoft Windows Operating Systems, MS Office tools and MS Server (2003 onwards)
  • Hyper-V/Virtual Computer Environments
  • Java

 

Location: Cambridge

 

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

By close of business 1st December 2014

 

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.

 

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.