Careers

Excellent opportunities have arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company. 

 

GW Pharmaceuticals was founded in 1998 and is listed on both the NASDAQ Global Market (GWPH) and AIM, a market of the London Stock Exchange,. GW is licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes. The Group's lead programme is the development of a product portfolio  of cannabinoid prescription medicines to meet patient needs in a wide range of therapeutic indications, including Sativex® Oromucosal Spray and Epidiolex® for childhood epilepsy.

 

GW has assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. GW maintains in-house control over all aspects of the cannabinoid product development process. GW also holds GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes

 

For details of GW’s current marketed product and international clinical research programme please refer to information on the company’s website: www.gwpharm.com .

 

To apply for an advertised position please send your CV together with a covering letter stating your salary expectations to recruitment@gwpharm.com.

 

Unfortunately we are currently unable to consider any speculative applications and so please do not apply for a position unless you believe yourself to be well suited to those advertised.

 

For all other recruitment enquiries please e-mail recruitment@gwpharm.com.

 

Due to the high volume of applications we receive if you do not hear from us within two weeks of applying then unfortunately you have not been successful on this occasion. We do thank you for your interest in working for GW and wish you every success with future applications.

Clinical Projects Assistant (Clinical Trials Assistant) - UK

 

Permanent or Fixed Term Contract

 

The Role

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

 

Key Responsibilities

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

 

Essential Skills

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

 

Location: Cambridge, UK

 

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

HR Advisor – South East UK

Permanent

 

The Role

To provide a proactive, responsive and business-focussed generalist HR service across GW.

To support the HR Director, and deputise for her, as and when appropriate.

 

Key Responsibilities

  • To partner with managers and colleagues across GW in the provision of a proactive, high quality HR service, areas to include the following:
  • Recruitment, selection and resourcing (in partnership with the recruitment team)
  • Performance management and employee relations
  • Reward and recognition
  • HR processes, systems and metrics
  • Learning and development (in partnership with the L&D team)
  • Other general HR and communications duties as required
  • To be key member of the HR team and to act as a role model for One GW behaviours and the GW Spirit (Ambition – Energy – Responsibility – Agility – Delivery – Teamwork).

Essential Skills

Knowledge:

  • Holds a full CIPD qualification or has equivalent experience or qualifications which match that level.
  • Good general level of educational attainment.
  • Has a strong and current knowledge of HR practices across the function

Experience:

  • Strong experience in most aspects of the HR, including recruitment and selection, performance management, employee relations and HR processes and systems.
  • Will have worked successfully in a fast paced, quickly changing, commercial environment.
  • Experience of working as a ‘business partner’ in close collaboration with line managers of all levels.
  • Ideally will have experience of working within the pharma or biotech sector.

Skills:

  • Strong communications skills (written and verbal), including ability and willingness to do presentations and deliver training.
  • Good IT and numeric skills, including working with HR information systems.
  • Ability to develop effective working relationships with a wide range of people at all levels.
  • Excellent attention to detail and sets high standards of accuracy for own work
  • Ability to work with flexibility in a demanding and frequently changing environment.
  • Able to problem solve and develop practical and commercial solutions.
  • Ability to coach and mentor others.
  • Ability to prioritise and manage workload and multiple projects effectively.

 

Location: South East UK

 

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

 

BDS Process Technician – UK

 

Permanent/FTC

 

The Role

The BDS Process Technician is responsible for processing Botanical Drug Substance (BDS) using a series of well-defined and documented manufacturing processes/procedures. Whilst being in compliance with Health and Safety (H&S) and current Good Manufacturing Practices (cGMP) requirements.

 

Key Responsibilities

  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job. 
  • Process manufacture of BDS. 
  • Recording of manufacturing/process conditions in batch documentation and equipment/area logbooks. 
  • Complete area/equipment cleaning procedures to high standards as illustrated in cGMP practices. 
  • Authoring and reviewing of batch documentation and Standard Operating Procedures (SOP). 
  • The Job Holder maybe called upon to provide cover for other internal departments, when the BDS Production schedule allows. 
  • Identifying areas for improvement and implementing these improvements, where applicable across all BDS Production processes/working practices.
  • Completing additional tasks assigned by Production management that are outside the core duties described above. 

 

Essential Skills

  • Experience gained in a regulated production environment, ideally within the pharmaceutical/chemical or food industry. 
  • Good level of numeracy. 
  • Good communication skills including written. 
  • A good working knowledge of standard Microsoft packages, i.e. Excel and Word. 
  • The ability to work on own or in a small team environment. 
  • Excellent attention to detail. 
  • Develops and maintains positive working relationships with key stakeholder groups, both internal and external. 
  • Prepared to challenge the norm and look for areas of improvement, share own ideas and information.  


Desirable

  • Ideally hold qualifications gained in the Pharmaceutical industry i.e. NVQ’s, or similar. 

 

Location: South East, UK 

 

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

Preclinical Co-ordinator – Cambridge, UK

 

Permanent

 

The Role

To support the Preclinical Team with document management and quality control to support pipeline development.

 

Key Responsibilities

  • Supporting the Preclinical Team members with departmental activities
  • Document Management and filing
  • Materials Forecast
  • Co-ordination of meetings, teleconferences and taking meeting minutes
  • Document Quality Control
  • Document formatting and referencing
  • Maintenance of preclinical teams SharePoint site. 

 

Essential Skills

Knowledge/ Experience:

  • Previous experience of working within an administration role
  • Working knowledge of Excel, Word, Outlook, PowerPoint, Endnote, search engines and databases used for literature searches
  • A degree  (BSc) in Pharmacology or another appropriate scientific discipline is desirable but not essential
  • Good organisational skills and the ability to prioritise
  • The ability to use initiative and problem solve
  • Excellent communication skills (both written and oral) and the ability to build effective relationships with researchers and colleagues
  • The ability to multi-task and think on your feet
  • Excellent attention to detail
  • The ability to work within a team, and as an individual
  • Demonstrates a ‘can do’ approach to work
  • The ability to motivate others
  • Shares ideas and information. 

Location: Cambridge, UK 

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

Clinical Quality Assurance Auditor – Cambridge, UK

 

12 Month fixed term contract

 

The Role

To provide objective assurance to GW management through the preparation, performance, reporting and follow-up of independent clinical quality assurance audits, that clinical trials are conducted in compliance with the relevant GxP guidelines, regulations and GW or other applicable standard operating procedures (SOPs).

 

To support operational staff through advice and training related to specific area of GxP, regulations and process knowledge and to identify process improvement opportunities through SOP review and audit activities.

 

Key Responsibilities

  • To assist the CQA Manager with the implementation and conduct of the CQA audit programme.
  • To assist with inspection readiness preparation and hosting of regulatory Inspections and external part audits of GW (Cambridge).
  • To assist with the preparation for clinical investigator site inspections (and associated GLP/GCLP/academic facilities) 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 amongst company personnel.
  • To assist with the development and maintenance of company GxP and quality standards by means of training, review, advice and guidance service.
  • Must be willing to travel nationally and internationally (expected travel 30-40%) 

 

Essential Skills

Knowledge/ Experience:

  • Knowledge and experience of working to pharmaceutical regulatory standards in clinical research and knowledge of international regulatory requirements for product registration.
  • Knowledge of GCP, GCLP and GLP international regulations with the ability to apply this knowledge to resolve day-to-day issues.
  • GCP international regulations and guidance, with the ability to apply this knowledge to resolve day-today issues.
  • Previous GCP auditing experience working in a pharmaceutical company or regulated industry.
  • Proven experience GCP auditing within a healthcare company or CRO, with demonstrated knowledge and experience of conducting a variety of audit types.

 

Skills:

  • A Bachelor’s degree or equivalent in a science discipline.
  • Excellent inter-personal and communication skills (written and verbal)
  • Good organisational skills
  • Excellent attention to detail and the ability to identify the root cause of problems. 

Location: Cambridge, UK 

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

Clinical Project Administrator - Raleigh, NC, US

 

12 month fixed term contract

 

The Role

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

 

Key Responsibilities

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

Essential Skills

  • Clinical Trial experience 
  • Organizational skills and prioritization
  • Ability to use initiative and problem solve
  • Able to work as a team and as an individual
  • Good communication skills
  • Excellent attention to detail

 

 Desirable Skills

  • Degree in life science or health science discipline preferred

 

Location: Raleigh, NC, US

 

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

Group Accountant – Cambridge, UK

Permanent

 

The Role

To lead improvements to the Group’s technical accounting

 

Key Responsibilities

  • Produce monthly & quarterly financial reporting documents on key accounting balances for the Group
  • Assist the Group Financial Controller and Financial Reporting Accountant to prepare UK & US reporting documents
  • Liaise with the Chief Financial Officer, wider finance team and key business stakeholders to produce accurate and timely technical accounting memos
  • Lead preparation of individual entity financial statements to support statutory compliance 

Essential Skills

  • Qualified chartered accountant – ideally with an audit background and dealing with listed company financial reporting or working in a technical accounting environment;
  • Strong technical ability;
  • Ability to be self-motivated and research new areas and provide advice to both senior and junior members of the business;
  • Strong communication skills, both written and verbal; and
  • Strong Microsoft Excel skills – being able to construct appropriate templates and working models that will be used by wider members of the finance team.

Desirable Skills

  • Experience of working in or with a US-listed company would be highly desirable
  • Knowledge of Sarbanes-Oxley compliant control environments would be advantageous;
  • Experience of Microsoft Navision accounting systems would be preferable

 

Location: Cambridge, UK

 

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

Clinical Research Associate/Senior Clinical Research Associate – Northern England/Midlands, UK

 

Fixed Term 12 Month Contract

 

The Role

Responsible for the day to day activities including set up, monitoring and completion of clinical trials in accordance with GW SOPs, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and relevant local and international regulatory guidelines.

 

Key Responsibilities

  • Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and Company guidelines.
  • Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
  • In accordance with GW SOPs, performs site management activities including:
    • site evaluation visits
    • site initiation visits
    • monitoring visits
    • closeout visits
  • Collaborates with the Core Project Team to drive subject recruitment
  • Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure compliance with applicable regulations and the protocol.
  • Is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Essential Skills

  • BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification.
  • Experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
  • Knowledge of relevant GW SOP’s, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and applicable regulatory guidelines.
  • Ability to travel to sites and be available for extensive travel including overnight stays, as required.
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail.
  • Able to use initiative and problem solve.
  • Flexible and adaptive approach to work.
  • Able to work in a team and as an individual.
  • Ability to identify issues and resolve appropriately with guidance.

 

Location: Northern England/Midlands, UK

 

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

 

Senior Manager/Associate Director of Regulatory Affairs – US

 

Permanent

 

The Role

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

 

Key Responsibilities

  • Plans, coordinates and participates in writing, preparation, assembly, and maintenance of US applications to regulatory authorities
  • Creates and manages submissions timelines and provides operational guidance and regulatory advice to submission teams
  • Builds and maintains relationships with other functions within GW
  • Maintains Regulatory Systems and provides administrative support
  • Other duties as required

Essential Skills

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

Desirable

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

Location:  RTP, North Carolina.  

 

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

Clinical Pharmacologist – Cambridge, UK

 

Permanent

 

The Role

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

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

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

 

Key Responsibilities

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

 

Essential Skills

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

 

Desirable

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

 

Location: Cambridge, UK

 

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

 

Principal Statistician - US or UK

 

Permanent

 

The Role

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

 

Key Responsibilities

  • Act as representative Statistician on study teams, so as to provide timely input.
  • Statistical input from inception through to reporting of Phase I, II and III studies, ensuring high scientific standards for all studies.
  • Perform statistical analyses of data and interpret results, ensuring validity of conclusions.
  • Respond to regulatory questions regarding submissions.
  • Provide valuable input into trial design and protocols.

 

Essential Skills

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

Desirable

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

 

Location: US – Field based East Coast or UK 

 

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

IT Support Analyst - UK

 

12 month fixed term contract/contract

 

The Role

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

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

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

 

Key Responsibilities

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

 

Essential Skills

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

 

Location: Cambridge, UK

 

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

 

Clinical Research Associate – Texas, US

 

Fixed Term Contract

 

The Role

Responsible for the day to day activities including set up, monitoring and completion of clinical trials in accordance with GW SOPs, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and relevant local and international regulatory guidelines.

 

Key Responsibilities

  • Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and Company guidelines.
  • Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
  • In accordance with GW SOPs, performs site management activities including:
    • site evaluation visits
    • site initiation visits
    • monitoring visits
    • closeout visits
  • Collaborates with the Core Project Team to drive subject recruitment
  • Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure compliance with applicable regulations and the protocol.
  • Is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Essential Skills

  • BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification and experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry.
  • Experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
  • Good knowledge of relevant GW SOP’s, ICH-GCP, The US Food and Drug Administration FDA Code of Federal Regulations Title 21 – Food & Drugs Good Clinical Practice Parts: 11, 50, 54, 56, 312 and 314  and other regulatory guidelines, as applicable.
  • Fluent in English and in the relevant native language.
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail with a proven track record for ensuring quality data and good site management.
  • Ability to travel to sites and be available for domestic and international travel including overnight stays, as required.
  • Able to use initiative and problem solve.
  • Flexible and adaptive approach to work.
  • Able to work in a team and as an individual.
  • Ability to identify issues and resolve appropriately with guidance.
  • Ability to process visit reports in a timely manner to an acceptable quality.

 

Location: Texas, US

 

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

 

Clinical Research Associate – IMP returns specialist – US

 

Fixed term contract - 18 months

 

The Role

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

 

Key Responsibilities

  • Ensures the integrity of clinical data in relation to IMP documentation and adherence to applicable regulatory, protocol and Company guidelines.
  • Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
  • In accordance with GW SOPs, performs site management activities pertaining to IMP accountability and return at :
    • monitoring visits
    • closeout visits
  • Collaborates with the US CRA and CPM teams to plan and schedule regular accountability and shipment of returns of a controlled IMP.
  • Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure compliance with applicable regulations and the protocol for IMP accountability and returns.
  • Is responsible for maintaining cGxP and H&S knowledge applicable to the job.

Essential Skills

  • BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification and experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry.
  • Experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
  • Good knowledge of relevant GW SOP’s, ICH-GCP, The US Food and Drug Administration FDA Code of Federal Regulations Title 21 – Food & Drugs Good Clinical Practice Parts: 11, 50, 54, 56, 312, 314 and 1308 and other regulatory guidelines, as applicable.
  • Previous experience of working with Schedule I and/or Schedule II controlled substances essential (Preferred).
  • Previous experience with shipping Dangerous Goods and current IATA Certification (Preferred).
  • Fluent in English.
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail with a proven track record for ensuring quality data and good site management.
  • Ability to be available for domestic and international travel including overnight stays, as required.
  • Able to use initiative and problem solve.

 

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

 

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

 

Regulatory Project Manager - UK

 

Permanent

 

The Role

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

 

Key Responsibilities

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

 

Essential Skills

Knowledge:

  • Degree in life sciences.

Experience:

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

Skills:

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

 

Location: South East, UK

 

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

Clinical Research Associate – Northern England/Scotland

 

Fixed Term 12 Months

 

The Role

Responsible for the day to day activities including set up, monitoring and completion of clinical trials in accordance with GW SOPs, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and relevant local and international regulatory guidelines.

 

Key Responsibilities

  • Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and Company guidelines.
  • Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
  • In accordance with GW SOPs, performs site management activities including:
    • site evaluation visits
    • site initiation visits
    • monitoring visits
    • closeout visits
  • Collaborates with the Core Project Team to drive subject recruitment
  • Establishes and maintains regular contact with Investigators, vendors and trial sites to ensure compliance with applicable regulations and the protocol.
  • Is responsible for maintaining cGxP and H&S knowledge applicable to the job.

 

Essential Skills

  • BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry.
  • Experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
  • Knowledge of relevant GW SOP’s, ICH-GCP, EU Directive 2001/20/EC, Commission Directive 2005/28/EC and applicable regulatory guidelines.
  • Ability to travel to sites and be available for extensive travel including overnight stays, as required.
  • Possess strong verbal and written communication, interpersonal and organisational skills.
  • Have a high degree of accuracy and attention to detail.
  • Able to use initiative and problem solve.
  • Flexible and adaptive approach to work.
  • Able to work in a team and as an individual.
  • Ability to identify issues and resolve appropriately with guidance.

 

Location: Northern England/Scotland

 

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

 

Clinical Trial Supplies Programme Manager - US

 

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: US

 

To apply please send your CV with salary expectations 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.

Please be aware the UK Government has taken steps to reduce net migration to the UK by limiting the number of overseas workers from outside the EEA coming to the UK for employment. Consequently, whilst we are able to consider applications from overseas workers from outside the EEA (who require a Tier 2 (General) Visa) we can only employ them if we can provide evidence that there are no other suitable candidates from inside the EEA.Therefore all Non-UK/EEA nationals’ applications will be kept on hold until we have pursued all candidates who currently have the right to work in the UK.