Careers

To apply for an advertised position please send your CV together with a covering letter or email stating your salary expectations to the person indicated.

For all recruitment enquiries please contact our HR department 01795 434178, or e-mail 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.

 

We are already working with a list of Recruitment Consultants which we will review on a monthly basis. If you wish to be considered please submit your terms and specialisms to recruitment@gwpharm.com please do not contact us by telephone 

 

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

 

Clinical Project Manager

 

9 month Maternity Leave

 

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

To execute Phase I-IV and other approved clinical studies according to ICH/GCP guidelines and regional regulations.  Have a hands on role in the 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. To lead development and maintenance of Product Development Plans by coordinating with other departments

 

Key Responsibilities

  • Manage sponsored clinical trials in various therapeutic areas as determined by the needs of the organisation.
  • 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.
  • Participate in the selection of all vendors for the responsible study and their supervision.
  • Manage timelines from project concept to delivery of the Clinical Study Report.
  • Present Product Development Plans to the Executive Management Team
  • Be responsible for maintaining cGxP and H&S knowledge applicable to the job.

Essential Skills

  • Broad Clinical Trial experience
  • A global view of drug development. 
  • experience of development of Product Development Plans
  • 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

Desirable Skills

  • Preferably with experience of clinical project management responsibilities and previous CRA duties

 

Location: Ideally Cambridge although field based would be considered.

 

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

By close of Business 27th November 2014,

 

Discovery Pipeline Project Assistant

 

Permanent

 

GW Pharmaceuticals the leading company in its field of research, development and supply of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic indications - are looking for a dynamic MA Graduate in Life Sciences to join the Discovery Pipeline Team as a Project Assistant.

The Discovery Pipeline Teams’ role is to understand opportunities (particularly those residing in the area of rare disease) and propose those most appropriate to become part of the clinical pipeline. To do so, the team are responsible for identifying and commissioning basic research as well as reaching out to physicians and patient advocacy groups in order to facilitate rapid translation into the clinic.

 

The Role

This is a new role within the company and as such the candidate will have plenty of opportunity to shape their own career path. Based in Cambridge with regular travel to London it will be the role of the Discovery Pipeline Project Assistant to assist the Discovery Pipeline Lead with two duties: [1] research, analysis and profiling of new development opportunities [2] planning, coordination and record keeping of preclinical/clinical projects.

 

The successful applicant will be a dynamic MA Graduate with a Life Sciences degree, must fully appreciate the role of systems biology in treating disease, and have entrepreneurial, strategic, and creative elements to their character. Experience in computer programming/graphics will be looked upon favourably. This is a brilliant opportunity for someone to develop within the organisation.

 

Key Responsibilities

  • Contributes to the strategy, planning and development of cannabinoid medicines in new therapeutic areas.
  • Brings structured and rigorous thinking into the very early stage pipeline.
  • Performs intelligence gathering duties from publically available sources.
  • Analyses internal GW reports and data sets to determine gaps in knowledge and additional basic science research requirements for development candidates.
  • Identifies key stakeholders and patient groups and academic institutes of excellence in relevant disease areas suitable for network engagement.
  • Maintains good working relationships with key opinion leaders and collaborative researchers/organisations.
  • Presents and communicate complex research and analysis to senior executives.
  • Acts as a conduit between the Pipeline Discovery group and the Preclinical and Clinical Operations teams to facilitate passage of projects through to those groups.
  • Participates in appropriate therapeutic area training as required in order to educate the Preclinical/Clinical Operations team with regard to each opportunity.
  • Supports the Discovery Pipeline Lead in the performance of their duties.
  • Represents the company at international meetings/symposia (where appropriate).
  • Executes additional tasks in order to meet departmental project-related or developmental / change objectives.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
     

Essential Skills

  • A higher degree (Master’s or higher) in one of the Life Sciences
  • Intimate understanding of systems biology is a necessary prerequisite
  • Experienced in the review of scientific literature
  • Experienced in scientific writing
  • Exceptional organisational skills and the ability to prioritise
  • High proficiency in Excel, Word, PowerPoint
  • Proficiency in search engines and databases used for literature searches
  • Good report writing skills and good communication skills
  • Good written and verbal presentation skills
  • Ability to use initiative and think strategically
  • Ability to direct, manage and motivate others
  • Excellent attention to detail
  • Ability to work in a team and as an individual
  • Demonstrates a pragmatic approach to problem solving
  • Self-motivated with a willingness to assist colleagues to achieve goals
  • A flexible approach to constantly changing priorities and ability to deliver results within challenging and changing timelines

 

Desirable Skills

  • Computer programming skills will be looked upon favourably
  • Experience in using graphical suites and software will be looked upon favourably
  • Basic knowledge of cannabinoids and the endocannabinoid system is desirable
  • General knowledge of the drug development process desirable
  • Experience using project management software helpful
  • Working knowledge of Endnote, Prism helpful

 

Location: Cambridge

 

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

By close of Business 25th November 2014.

Regulatory Team Leader (Clinical)

 

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

Management of the Regulatory aspects of Clinical Trials Applications worldwide and of the team undertaking these activities in Cambridge.

 

Key Responsibilities

  • Development and management of the Regulatory clinical team in Cambridge.
  • Management of Clinical Trial Applications (CTAs) worldwide.
  • Attendance at key Clinical, Nonclinical and Pharmacovigilance meetings requiring Regulatory input.
  • Ensuring Regulatory compliance; maintaining cGxP applicable to the job.

 

Essential Skills

  • Degree level education in Life Sciences.
  • Extensive working knowledge of clinical trial submissions in Europe and globally and some knowledge of quality and safety disciplines.
  • Experienced line manager.
  • Good organisational skills.
  • Communication skills including written and presentational.
  • IT competency. [RB1] 
  • Creative yet attention to detail and regulatory guidance.
  • Commercial awareness.
  •  

Location: Cambridge

 

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

By close of Business 21th November 2014

 

Regulatory Specialist - Clinical Trials

 

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

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

 

Key Responsibilities

  • Compilation and management of Clinical Trial Applications
  • Maintenance and tracking of key regulatory documentation
  • Building and maintaining relationships with other functions within GW
  • Maintaining and development of Regulatory Systems and administrative activities
  • Maintaining cGxP applicable to the job

 

Essential Skills

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

 

Location: Cambridge

 

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

By close of business 20th November 2014

Senior Clinical Project Manager

 

Permanent (Full time or part time may be considered)

 

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

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.
  • 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. 
  • 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 gained over 4+ years. 
  • Knowledge of relevant SOP’s, ICH/GCP and regulatory guidelines. 
  • Experience in leading global studies.
  • Experience in paediatric studies.
  • Experience in regions such as The Netherlands, Israel, UK, Spain and France.
  • Good communication skills.
  • Able to work in a team and as an individual
  • Ability to lead, direct, manage and develop others. 
  • Organisation skills and prioritisation
  • Able to use initiative and problem solve
  • General understanding of budgetary control
  • A global view of drug development, preferably with experience of clinical project management responsibilities and previous CRA duties
  • Full driving licence. 
  • Able to travel

 

Location: Cambridge or home based

 

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

By close of play 14th November 2014

 

Senior Device Development Engineer/Scientist

 

FTC 18 months

 

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

  • Project Management of internal and outsourced device development projects.

 

Key Responsibilities

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

 

Essential Skills

Knowledge:

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

Experience:

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

Skills:

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

 

Location: South East 

 

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

By close of play 19th November 2014. Interviews will be held the 1st week of December.

 

 

 

Supply Chain Director Role

 

Permanent, FTE

 

GW Pharma Ltd is the leading company in its field of research, development and supply of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic indications.

In parallel to the continued commercial roll out of key product Sativex® for patients with Multiple Sclerosis, the company is continuing phase three clinical trials in patients with advanced cancer, expanding activities in the field of epilepsy and about to embark on a significant period of internal investment and improvement. Therefore we are looking to strengthen our busy and expanding Supply Chain operations with the appointment of a Supply Chain Director

 

The Role

The job holder will be comfortable working alongside and reporting into Senior Director level, and will be a key member of the company’s senior management team.  The job holder will lead a range of strategic and operational supply activities within the company to meet current and future business needs.  The role will be varied, involve significant internal and external stakeholder engagement and will head-up a complex supply chain delivering Clinical, Commercial and Controlled Drug temperature sensitive products to time-critical international destinations.

 

Key Responsibilities

The Supply Chain Director holds overall responsibility for all aspects of GW’s drug supply operations.  These responsibilities include, but are not limited to:

 

  • Commercial Partner demand planning and commercial partner primary interface
  • Commercial Controlled Drug pick/pack/dispatch operations
  • Inventory, replenishment, vendor and 3PL management
  • Overseeing all finished stock and raw material warehousing; inbound and outbound supplies
  • Cool-chain and ambient drug distribution including export controls and import / export licensing
  • Direct liaison with external Regulatory Authority and Legislative organisations for all supply matters
  • Responsibility for ensuring appropriate arrangements in place for compliance to the Single Convention on Narcotics Drugs and country estimate requirements (as administered by the INCB), for all company needs
  • Demand planning and forecast modelling and lead of the company’s S&OP activities
  • Factory planning and manufacturing and testing work-flow scheduling
  • Packaging, artwork and printed literature management and development
  • Supply Chain function capital and operational expenditure budgeting
  • Direction, motivation, development and employee engagement of all Supply Chain staff, team c10
  • Establishment and performance management to appropriate pharmaceutical supply chain KPI’s

 

 

Essential Skills

The job Holder should

  • have worked alongside a diverse range of internal and external stakeholders including partners, suppliers, medical professionals, depots, distributors and international Regulatory and Legislative Authorities.
  • have a strong Pharmaceuticals senior management background.
  • have excellent report writing skills
  • have presentation and communication skills both orally and in writing.
  • be an experienced and senior Pharmaceutical Supply Chain professional with exquisite planning, project management, people management, inter-personnel and IT skills – all essential to succeed in this post. 
  • be proficient in the utilisation of current ERP, MRP, IVRS and WM electronic systems and experience of working to MHRA and FDA requirements.
  • have a comprehensive understanding of GMP and GDP
  • have previous experiences of implementing Continuous Improvement and LEAN tools within a pharmaceutical supply chain are required.
  • be able to anticipate and identify areas of risk and inefficiency within the GW supply chain and to recommend and implement appropriate solutions to address.
  • have a strong understanding of operational Health and Safety within supply operations.

 

Location: South East

 

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

By close of play 2nd December 2014.

 

Director of Quality/QP

 

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

 

The Role

We are seeking a Director of Quality to support the current incumbent and move into this role as part of the medium term succession plan.

We are going through a significant period of growth and expansion, and with several fast track programs especially in the US requiring strategic Quality input, this is an exciting time for the right person to join us and help us achieve our challenging objectives!

 

This role will initially report to and deputise for the Director of Quality during the transition phase.

 

Key Responsibilities

GW runs a single over-arching quality system, with site based teams responsible for local quality systems feeding into it.  The role will include providing strategic direction to, and managing, the Quality team as well as advising in all aspects of the Quality Management System for the various GxPs and supporting the Training and Development team in ensuring that GxP knowledge is kept current and maintained.

You will have particular responsibilities for the strategic quality aspects of the company’s new pipeline products in the therapeutic area of epilepsy using program planning to manage. 

This is a key role within the senior management team and will cover all GxP areas ranging from Good Agricultural Practice through to cGMP and GCP as well as GVP and GLP and training and development.

You will ensure that effective and efficient Quality support is provided to our Clinical and Commercial teams across our sites, whilst providing strategic overview and support for a Continual Improvement culture using Key Performance Indicators/Metrics.

 

Essential Skills

  • Management experience in an MHRA/FDA regulated environment
  • Excellent working knowledge of current ICH, EU and US regulatory requirements and their implementation
  • Experience in a global market and global quality management systems
  • Experience in Investigational Medicinal Product (IMP) and Commercial product types
  • Qualified Person eligibility under the permanent provisions
  • Current cGMP knowledge as well as having a good understanding of GCP and GVP and the ability to support the Clinical and Commercial teams across GW
  • Good operational knowledge and experience
  • Demonstrable experience of thinking and operating at a strategic level
  • Strong ability to work on own initiative, with excellent planning and prioritisation skills
  • Ability to successfully network both internally and externally
  • Excellent leadership, negotiation and influencing skills
  • Excellent communication skills
  • Problem solving and solutions focussed person
  • Experience with natural products and a good knowledge of the Regulatory process would also be an advantage
  • A full clean driving licence is required together with the flexibility to travel to other sites as required for the role.

 

Location: London – with travel to other sites

 

To apply for this position please send your CV together with a covering letter by 21 November, telling us why you are suitable for this post to recruitment@gwpharm.com.  It is expected that first interviews will be held by the end of November.

 

 

 

Clinical Compliance Officer

 

 12 Month FTC

 

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

To promote GCP compliance and process improvements across Clinical Operations and associated functions through both implementation of Corrective and Preventive Actions (CAPAs) for findings arising from audits/inspections, and Standard Operating Procedure (SOP) updates.

 

Key Responsibilities

  • Drive the process of responding to findings and developing CAPAs for investigator site, systems and process audits, and inspections by external agencies (e.g. MHRA, FDA and partners), across Clinical Operations
  • Chair/key contributor to working parties focussed on specific areas of CAPA resolution (e.g. trial start up)
  • Responsible/Accountable to the GCP Compliance Steering Committee for CAPA resolution targets
  • Chair/facilitate Clinical Process Improvement Team, which aims to address issues, identified within CPM/CRA/Clinical Coordination teams, which require cross-functional action/decisions – e.g. CPM action log items, process improvement initiatives.
  • Ensures appropriate tracking of process improvement initiatives.
  • Promote and drive continual process improvement, in line with best practice and regulations
  • Initiate, consult on, implement and provide training (in association with Training & Development Manager and relevant departmental managers) on agreed process improvement initiatives
  • Support departmental inspection readiness activities
  • Draft Standard Operating Procedures (SOPs) and SOP updates, and contribute to SOP globalisation
  • The job holder is responsible for maintaining GCP and H&S knowledge applicable to the job.

 

Essential Skills

  • Substantial experience working in the Pharmaceutical industry in a Clinical Monitoring, Project Management, Quality Assurance or similar role
  • Educated to A-level or above
  • Detailed working knowledge of GCP and current regulations governing clinical trial conduct
  • Attention to detail and methodical approach; strong track-record of ensuring full completion/implementation of activities
  • Computer literate in Microsoft packages
  • Strong communication skills (written and oral)
  • Ability to influence/motivate colleagues, and to promote effective team working
  • Flexible and adaptable to a fast-changing environment
  • Responsible and reliable
  • Excellent time management and organisational skills

Desirable Skills

  • Degree in Biological Science/Nursing Qualification or equivalent
  • Experience on global clinical trials
  • Experience of MHRA/FDA inspections

 

Location: Cambridge

 

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

By close of play 17th November 2014. Interviews will take place at the beginning of December 2014.

 

Clinical Projects Assistant (Clinical Trials Assistant)

 

 

12 Month FTC

 

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

Clinical Projects Assistants are responsible for the administration, coordination and tracking of clinical trials (Phases 1-4). Key tasks are the establishment and maintenance of paper and electronic filing systems (including TMF management), provision of support to Clinical Research Associates and Project Managers during the set-up, monitoring and close-down phases of clinical trials, assist with ethics committee applications, liaison with suppliers and CROs, and tracking of overall project progress. The selected candidate will play a key role in the set-up and coordination of a program of Phase 3 paediatric trials.

 

Key Responsibilities

  • Coordination and tracking of clinical projects.
  • Provide support to Clinical Operations Managers (COMs), Clinical Project Managers (CPMs) and Clinical Research Associates (CRAs) during the life of the clinical trial.
  • Set up and maintenance of paper and electronic trial filing systems.
  • Provide support to Clinical Coordination Department.
  • Assist in development of Clinical Coordination systems and procedures.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

 

Essential Skills

  • Direct, relevant experience as a Clinical Projects Assistant or similar role in either a CRO or Pharmaceutical business
  • Knowledge of relevant regulatory guidelines and legislation
  • Experience of Coordinating and tracking of clinical projects.
  • Self confidence and initiative.
  • Excellent attention to detail.
  • Good interpersonal skills – including oral and written communication skills.
  • Basic project management skills.
  • Able to work in a team and as an individual.
  • Working knowledge of MS Outlook, Word, Excel and PowerPoint.

 

 

Location: Cambridge

 

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

By close of play 14th November.

 

Experienced Senior Clinical Quality Assurance Auditors Required in USA (Field-based Positions) – 1-Year Contract

 

1 year FTC

 

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

 

The Role

As an experienced Senior Clinical  Quality Assurance Auditor within a multi-disciplined company, you will utilise your GCP auditing expertise, regulatory knowledge and excellent communication skills to support the audit programme for clinical development.  You will also be expected to plan, conduct and follow-up investigator site audits, process audits, vendor audits, internal audits and documentation audits, with the auditing occupying about 80% of working time in the USA or abroad.  In addition, you will provide support, advice, education and training to other departments involved in GW clinical trials.

 

You will support GCP regulatory inspections; assist with the set-up, review and maintenance of SOPs within Clinical Development and support the development, maintenance and audit of documentation intended for regulatory submission.

 

This will be a broad based position, providing exposure to all aspects of drug development.  The position is field-based within the USA and reports to the Head of Clinical QA (in the UK).  It is a highly interactive role, requiring self-reliance, excellent organisational and communication skills, effective strategic thinking and planning skills, the ability to operate effectively within a busy team, and build influential relationships both internally and externally. 

 

Key Responsibilities

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

 

Essential Skills:

  • A Biological Science Degree or Nursing qualification is preferred
  • Demonstrated experience of working in a GCP auditing role
  • Experience in the conduct of most of the following audit types:-
  • Investigator Site Audits
      • Vendor audits
      • Process audits
      • Documentation audits
  • Experience of dealing with FDA inspections (GCP)
  • Excellent organisational skills
  • Able to work independently or as part of a team
  • Good at multi-tasking and working to agreed deadlines.
  • Excellent attention to detail with the ability to identify the root cause of problems
  • A full driving licence is required along with the ability to travel approximately 50% of the time, both within the USA and overseas.

 

 

This is a 1-year Contract Position (40 hours per week), with about 80% of the time spent auditing (internally or externally as per the business needs).

 

If you believe that you have the skills and drive to succeed in this role, we can offer competitive remuneration and benefits.

 

Location:  USA (Field-based Position)

 

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

By close of play 17th November 2014

 

 Senior Clinical Quality Assurance Auditors Required – 2-Year Contract

 

FTC

 

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

  

The Role

As a Senior Clinical Quality Assurance Auditor within a multi-disciplined company, you will utilise your GCP auditing expertise, regulatory knowledge and excellent communication skills to support the audit programme for clinical development.  You will also be expected to plan, conduct and follow-up investigator site audits, process audits, vendor audits and documentation audits, with the auditing occupying about 80% of working time in the UK or abroad.  In addition, you will provide support, advice, education and training to other departments involved in GW clinical trials, and may also be required to train other members of the Clinical QA team.

 

Key Responsibilities

You will support GCP regulatory inspections; assist with the setup, review and maintenance of SOPs within Clinical Development and support the development, maintenance and audit of documentation intended for regulatory submission.

 

This will be a broad based position, providing exposure to all aspects of drug development.  Reporting to the Clinical QA Manager and based from GW’s Clinical Development office in Histon, Cambridgeshire (for Internal Process audits); at the various audit sites (UK or abroad – for Investigator Site and Vendor audits);  and with a degree of home-based working (for Documentation audits and audit report writing / audit preparation) - this is a highly interactive role, requiring self-reliance, excellent organisational and communication skills, effective strategic thinking and planning skills, the ability to operate effectively within a busy team, and build influential relationships both internally and externally. 

 

Essential Skills

  • A Biological Science Degree or Nursing qualification is preferred
  • Demonstrated experience of working in a GCP auditing role
  • Experience in the conduct of most of the following audit types:-
  • Investigator Site Audits,
    • Vendor audits,
    • Process audits
    • Documentation audits
  • Excellent organisational skills
  • Able to work independently or as part of a team
  • Good at multi-tasking and working to agreed deadlines.
  • Excellent attention to detail with the ability to identify the root cause of problems
  • A full driving licence is required along with the ability to travel approximately 50% of the time, both within the UK and overseas.

 

This is a 2-year Contract Position (40 hours per week), with about 80% of the time spent auditing (internally or externally as per the business needs).

 

If you believe that you have the skills and drive to succeed in this role, we can offer competitive remuneration and benefits.

 

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

 

Closing Date:  17th November 2014

 

Experienced  Pharmacovigilance / Clinical Quality Assurance Auditor Required – 2-Year Contract

FTC

 

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

 

The Role

As an experienced Pharmacovigilance and Clinical Quality Assurance Auditor within a multi-disciplined company, you will utilise your GVP and GCP auditing expertise, regulatory knowledge and excellent communication skills to lead the pharmacovigilance audit programme and  to support the audit programme for clinical development.  You will also be expected to plan, conduct and follow-up Pharmacovigilance audits and maintain the audit annex to the PSMF  In addition, you may also conduct investigator site audits, process audits, vendor audits and documentation audits, with the auditing occupying about 80% of working time in the UK or abroad.  In addition, you will provide support, advice, education and training to other departments involved in GW clinical trials and pharmacovigilance activities, and may also be required to train other members of the Clinical QA team.

 

Key Responsibilities

You will support PV and GCP regulatory inspections; assist with the setup, review and maintenance of SOPs within Clinical Development and Pharmacovigilance and support the development, maintenance and audit of documentation intended for regulatory submission.

 

This will be a broad based position, providing exposure to all aspects of drug development and post-marketing data.  Reporting to the Clinical QA Manager and based from GW’s Clinical Development office in Histon, Cambridgeshire (for Internal Process and PV audits); at the various audit sites (UK or abroad – for Investigator Site and Vendor audits);  and with a degree of home-based working (for Documentation audits and audit report writing / audit preparation) - this is a highly interactive role, requiring self-reliance, excellent organisational and communication skills, effective strategic thinking and planning skills, the ability to operate effectively within a busy team, and build influential relationships both internally and externally. 

 

Essential Skills

  • A Biological Science Degree or Nursing qualification is preferred
  • Demonstrated experience of working in a GVP and GCP auditing role
  • Experience in the conduct of the following audit types:-
    • Investigator Site Audits,
    • Vendor audits,
    • Pharmacovigilance audits,
    • Process audits
    • Documentation audits
  • Excellent organisational skills
  • Able to work independently or as part of a team
  • Good at multi-tasking and working to agreed deadlines.
  • Excellent attention to detail with the ability to identify the root cause of problems
  • A full driving licence is required along with the ability to travel approximately 50% of the time, both within the UK and overseas.

 

This is a 2-year Contract Position (40 hours per week), with about 80% of the time spent auditing (internally or externally as per the business needs).

 

If you believe that you have the skills and drive to succeed in this role, we can offer competitive remuneration and benefits.

 

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

 

Closing Date:  17th November 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.

 To apply for any of our roles advertised please send your CV with covering letter and salary expectations to:


Human Resources
GW Pharma Ltd
Building 114
Porton Down Science Park
Salisbury
Wiltshire
SP4 0JQ

or by email to:

recruitment@gwpharm.com

 

 

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