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.

Regulatory Specialist - UK

 

Permanent

 

The Role

Within this role you will be responsible for performing & reviewing regulatory affairs activities, including the maintenance of new and existing product registrations world-wide.You will also be responsible for compiling, coordinating and submitting clinical trial/investigational new drug applications (CTA/IND).

 

Key Responsibilities

  • Preparation of CTA/IND submission and maintenance documentation.
  • National Submissions/MRP/DCP and CP; Life-cycle management/Post marketing: Type IA, IB and II Variations, and Renewals; Labelling, PIL's and SmPC's.
  • Prepare and review new product dossiers and annual updates.
  • Responsible for Regulatory maintenance activities including IB updates and annual reports.
  • Ensure regulatory systems, such as Regulatory Database /trackers are implemented and kept up to date.
  • Review updates to the regulatory environment and suggest impacts.

 

Essential Skills

 

Knowledge:

  • Relevant life sciences degree.
  • Experience in regulatory affairs.

 

Ideally experience in:

  • Preparation and maintenance of CTA submissions.
  • Type I & II variations.
  • Planning of Regulatory maintenance activities.
  • Preparation and control of Product Information. 

Skills:

  • Good organisational and prioritisation skills.
  • Good communication skills.
  • IT competency - Excel / Word / PowerPoint.
  • Excellent attention to detail/accuracy.
  • Demonstrated ability to write good quality documents. 

 

Location: Cambridge, UK

 

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

BDS Process Technician, South East, UK

 

Permanent

 

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.

The BDS Process Technician will also have the responsibility of being the back-up for the BDS Production Line Lead in their absence. Working hours are 08:00 – 16:30.

 

Key Responsibilities

  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job.
  • Process manufacture of BDS.
  • In the absence of the BDS Production Line Lead, provide day-to-day leadership, support and direction to the team, to include dealing with routine staffing matters occurring within their team, referring issues up the line as required.
  • In the absence of the BDS Production Line Lead, Compiling the Home Office returns and liaising with other departments to ensure that the figures are correct.
  • 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.
  • Completing/reviewing deviations and change controls that may occur during the running of BDS Production Departments.
  • 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.
  • The Production Department is subject to regular visits by senior management, external bodies and regulatory authorities. The BDS Process Technician will be called upon to conduct tours of the BDS Production Facility.
  • Identifying areas for improvement and implementing these improvements, where applicable across all BDS Production processes/working practices.
  • Training of –other Technicians on new processes/changes to manufacturing techniques.
  • Act as key Point of Contact (POC) for all key stakeholders (groups), in the absence of the Production Manager/Extraction Manager/BDS Team Leader.
  • Completing additional tasks assigned by Production management that are outside the core duties described above 

Essential Skill 

  • 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.
  • Good Team worker assists colleagues as and when required.
  • Demonstrates a ‘can do’ attitude. 

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

Horticultural Technician - South East UK

 

Permanent

 

The Role

To be part of the horticultural team involved with the propagation, maintenance, harvest and processing of research and commercial crops. The candidate must work within a GxP environment and operate within the bounds of standard operating procedures.

 

Key Responsibilities

  • Planting of seed
  • Preparation of cuttings
  • Planting of crops
  • Watering
  • Application of bio control
  • Crop monitoring
  • Harvest of crop
  • Processing and packing
  • Documentation and audit
  • Weekend duties
  • Maintenance and cleaning as required
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job
  • Carries out their work in a way that will not adversely affect their own, or others’, health, safety and security or the environment and reports any shortcomings in GW arrangements

 

Essential Skills

  • Experience of team working
  • Experience of a quality controlled environment within the workplace
  • Can demonstrate a practical interest and knowledge of basic horticulture
  • Flexible aptitude for lone or team working
  • Excellent attention to detail
  • Good level of computer literacy and competent use of Excel spreadsheets

 

Desirable Skills

  • Develops and maintains positive working relationships with others
  • Shares ideas and information
  • Assists colleagues as and when required
  • Demonstrates a ‘can do’ approach
  • Open and honest with reporting of faults, mistakes or errors noted within the work environment
  • Folk Lift Truck License
  • First Aid Training
  • Health and Safety representative and Training

 

Location: South East, UK

 

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

Regional MSL Manager, US - Various locations accepted - Large airport access required

 

The role

The Regional Medical Science Liaison (MSL) Manager will lead a regional field-based MSL team, functioning as an extension of the US Medical Affairs organization. Working with Medical Affairs leadership, the Regional Manager will provide strategic and operational support for executing the MSL tactics as well as ongoing territory development. This position will involve oversight of key MSL programs regionally and nationally as necessary. The strategic areas of focus include scientific exchange, health-care decision maker education, and research. MSLs are responsible for developing and enhancing professional relationships with medical thought leaders involved in various phases of product development, and the Regional Manager will be critical to successfully meeting these objectives at the individual and field-team levels.

 

Key Responsibilities

 

  • Develop and execute field business plans based on the US Medical Affairs strategic plan
  • Hire and train MSL team members 
  • Structure and lead a regional team of MSLs to provide innovative and optimized medical leadership during a US product launch
  • Interpret and translate national strategies into MSL territory business plans that include development and engagement with regional opinion leaders. Opinion leader development includes appropriate engagement with disease experts in research, as speakers, as advisors and other disease related activities
  • Manage and develop a regional team of MSLs including hiring, field training, evaluation, motivation, and disciplinary activities in alignment with GW’s corporate strategies and objectives. Provide strong leadership to motivate MSLs and achieve excellent results that align with corporate goals and culture
  • Ensure that all interactions and activities in the region comply with GW business guidance, policies, and SOPs, FDA, and PhRMA guidelines/policies
  • Maintain relationships with a small list of national level opinion leaders within their region to enhance engagement for strategic initiatives
  • Guide and assist the MSLs in the coordination of opinion leader interactions across the region and with other external stakeholders as necessary
  • Develop and maintain productive and appropriate relationships with individuals across the organization to include commercial and clinical development
  • Appropriately partner with the commercial field team and corporate team to provide necessary and appropriate medical resources in the region and corresponding districts
  • Clearly communicate national, regional, and territory plans and tactics; define, clarify and manage regional team priorities; actively support the regional team within their scope of responsibility by being their advocate and spokesperson; promote collaboration within the team, across work groups and with customers
  • Collaborate within medical affairs to appropriately respond to unsolicited requests for pipeline or off-label information
  • Represent the MSL function on US medical affairs teams as necessary

 

Requirements:

  • Master’s level scientific education required. MD, DO, PharmD, or PhD strongly preferred
  • Relevant industry experience; people management experience is required; product launch experience highly desired
  • Experience building MSL business plans based on medical affairs strategy is required
  • Experience building an MSL team for a new organization is preferred
  • Field experience as an MSL is required
  • Experience and expertise in the field of epilepsy is preferred; Neurology therapeutic area experience is required
  • Excellent communication, presentation and time management skills are required; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization
  • Strong understanding of US legal, regulatory, and compliance regulations and guidelines is required
  • Strong capabilities working with digital platforms and tools are required
  • Ability to travel at least 50% of the time

 

Location: US, Various locations accepted – Large airport access required

 

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

Contracts Administrator – Cambridge UK – 12 Month FTC

 

The Role

 

  • To assist the Finance Department with the tracking, logging and administration of contracts, including the budgeting for and payment of periodic payments under contracts, as required in coordination with management and Legal Department

 

Key Responsibilities

 

  • Maintaining computer databases for logging and tracking performance of executed contracts and key terms of such contracts
  • Administering contract monitoring and contract administration activities
  • Conferring with other internal departments concerning contract milestone achievement, payments and compliance
  • Coordinating with the Legal Department and other members of the Finance Department to ensure proper forecasting, budgeting, invoicing and collection of contractual revenue
  • Developing and preparing regular reports on the status of contracts and contract milestones
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job

 

Essential Skills

  • Law degree or degree in another subject that contained one or more modules on contract law (such as business administration or business development), or demonstrable experience of understanding contracts and contract law
  • Comprehensive knowledge and experience of using Excel
  • Comprehensive knowledge of other relevant software (Windows, Word, Outlook, Databases)
  • Ability to prepare clear and concise reports
  • Effective documentation skills, as well as strong team working and interpersonal skills
  • Ability to communicate and to establish relationships at all levels
  • Excellent organisational skills
  • Attention to detail and methodical approach
  • Flexible and collaborative approach to working with all departments and stakeholders
  • Ability to prioritise and adapt in a rapidly changing environment

 

Desirable Skills

  • Experience in contract administration or as a paralegal in a company or law firm
  • Knowledge of pharmaceutical development and the life science industry

 

 

Location: Cambridge, UK

 

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

HR Specialist Carlsbad, US

 

The role

GW is looking for a well-rounded HR Specialist with a breadth of HR experience to join our growing US HR team. The role will be based in Carlsbad, CA, our US headquarters. This role will have a broad range of HR responsibilities supporting our US operations including talent acquisition, benefits, compensation, and HRIS. This individual will be focused on implementing and administering human resources programs, policies, and practices. The majority of the employee population is field based, so having strong communication skills and being able to coordinate across multiple time zones is important. A successful candidate must have a strong understanding of HR fundamentals, business, and be customer oriented.

                          

Key Responsibilities

             Talent Acquisition

  • Prepares interview schedules and helps coordinate interview logistics
  • May collect documents from candidates
  • Prepares offer letters
  • Ensures successful onboarding of new employees
  • Leads new hire orientations
  • Partners with and supports US Talent Acquisition Lead 

             Benefits

  • Administers and communicates the company's benefits programs in regard to plan options, policy features, enrollment and other requirements.
  • Manages time off accruals, requests and approvals.
  • May assist in planning, developing, and redesigning company benefits programs and analyzing benefit costs.
  • May be involved with communication and implementation of wellness and health education initiatives.
  • Ensures company compliance with federal and state law 

            Compensation

  • Champion and administer company recognition and reward programs.
  • Performs activities to develop, implement and administer compensation policies and programs.
  • Audits jobs for content and prepares job descriptions reflecting job responsibilities, activities, duties and requirements.
  • Develops and/or participates in compensation surveys to collect and analyze competitive salary information to determine company's competitive position.

             HRIS

  • Maintains internal files and develops custom reports to meet the requirements of Human Resources, management, and staff.
  • Will assist in the development, implementation and maintenance of human resource information systems (HRIS) associated with the collection, retrieval, accessibility and usage of employee information for Human Resource department planning and activities.
  • Works with Human Resources to evaluate HRIS needs and may design new HRIS to meet changing demands.
  • Partners with payroll and UK HR team.  

            Other

  • Partners with colleagues across the company in numerous functions to manage governance, risk & compliance.
  • Other duties as assigned.
  • Travel may be required. 

Requirements

  • Previous HR experience and an in-depth understanding of the HR body of knowledge
  • Bachelor’s degree preferred, but not required
  • Previous experience in the life sciences industry is preferred, but not required
  • Multi-state payroll experience strongly preferred
  • Ability to maintain a high level of confidentiality and discretion
  • Excellent judgment, professionalism, diplomacy and tact are critical
  • Outstanding organizational and time management skills
  • Strong verbal and written communication skills
  • Excellent attention to detail
  • Strong Microsoft Office skills
  • Previous HRIS experience (Workday experience is a plus) 

Location:  Carlsbad, US 

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

Supply Chain Vendor Scheduler / Buyer – South East, UK

 

FTC – 8 months

 

The Role

To support the end to end Supply Chain Vendor Scheduling activities for the business, ensuring efficient and smooth operation.

 

Key Responsibilities

  • Materials management and allocation for key company materials and supplies
  • Prepare purchase orders
  • Purchase order co-ordination including supplier liaison, purchase order creation and monitoring
  • Confer with QA and vendors to discuss defective or unacceptable goods or services and assist in determining corrective action
  • Maintain and review manual records of items purchased, costs, delivery, product performance, and inventories
  • Monitor shipments to ensure that goods come in on time, and in the event of problems trace shipments and follow up on undelivered goods
  • Monitor changes affecting supply and demand
  • Completion of monthly stock movement reporting and analysis
  • To participate and help facilitate as needed in appropriate supply chain operational and continuous improvement projects
  • Initiate projects to reduce the total cost of raw materials and packaging goods
  • Support six monthly stock checks 

Essential Skills

  • Experience in a similar Supply Chain position
  • Pharmaceutical industry experience desirable
  • Self-motivation and exceptional commitment
  • Excellent interpersonal and communication skills
  • Attention to detail and delivery of accurate data
  • Strong planning, organisational and analytical skills
  • Knowledge of IT systems and software including ERP (Enterprise Resource Planning) software and MS Office software especially Excel
  • APICS Certification is a plus ( CFPIM, CPIM or CSCP)

 

Location: South East, UK 

 

To apply please send your CV with salary expectations to recruitment@g-pharm.com

QC Technician or Senior Technician - South East, UK – Permanent

 

The Role

Test and report on raw materials, intermediates, finished products and stability samples according to registered specifications, to enable product release and meet regulatory requirements under the direction of the Senior QC Scientist and/or QC Manager. To work in accordance with cGMP at all times.

 

Key Responsibilities

  • Perform analytical testing using GC, HPLC, TLC, FTIR and other required techniques in accordance with written procedures
  • Provide clear and accurate records of all work performed
  • Record data into appropriate records and notify the Senior QC Scientist and/or QC Manager of any OOS, OOT, OOE or questionable results
  • Create and update documents in accordance with cGMP and company procedures 

Essential Skills

Knowledge:

  • If no previous laboratory experience, educated to A-Level or equivalent in Chemistry/Science as a minimum

 

Experience:

  • With no relevant qualifications, thorough experience of working in a pharmaceutical or other regulated laboratory is required
  • No experience required with relevant qualifications

Skills:

  • Good communication and team working skills
  • Competent in the use of computers and general Microsoft Office software packages including Excel, Word, PowerPoint and Outlook
  • High level of numeracy
  • Excellent attention to detail and ‘concern for quality’


Attributes and Behaviours:

  • Develops and maintains positive working relationships with others
  • Shares ideas and information through open and honest communication
  • Assists colleagues as and when required
  • Demonstrates a ‘can do’ approach

 

Location: South East, UK

 

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

QC Scientist  - South East, UK – Permanent

 

The Role

Test and report on raw materials, intermediates, finished products and stability samples according to registered specifications, to enable product release and meet regulatory requirements under the direction of the Senior QC Scientist and/or QC Manager. To work in accordance with cGMP at all times.

 

Key Responsibilities

  • Perform analytical testing using GC, HPLC, TLC, FTIR and other required techniques in accordance with written procedures
  • Provide clear and accurate records of all work performed
  • Record data into appropriate records and notify the Senior QC Scientist and/or QC Manager of any OOS, OOT, OOE or questionable results
  • Create and update documents in accordance with cGMP and company procedures

 

Essential Skills

Knowledge:

  • Educated to degree level in chemistry (or related science based subject) as a minimum
  • Knowledge of cGMP regulations required
  • Knowledge of analytical testing and the use of analytical instrumentation, including HPLC and GC

Experience:

  • Experience working in a pharmaceutical or other regulated laboratory
  • Experience of using routine analytical instruments (HPLC, GC, IR, UV, etc) and of routine analytical techniques (titration, pipetting, etc) is required

Skills:

  • Good communication and team working skills
  • Competent in the use of computers and general Microsoft Office software packages including Excel, Word, PowerPoint and Outlook
  • High level of numeracy
  • Excellent attention to detail and ‘concern for quality’

Desirable

  • Experience of Pharmacopoeial testing and/or the use of Pharmacopoeias
  • Experience of stability testing and ICH guidelines
  • Experience working to cGMP in a pharmaceutical QC laboratory
  • Knowledge and experience of Empower CDS

Location: South East, UK

 

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

Senior Clinical Quality Assurance Auditors – Cambridge or Field Based –12 & 18 month FTC

 

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 Clinical Quality Assurance (CQA) Manager with the set-up, implementation and conduct of the CQA audit programme.
  • To act as audit programme lead for an assigned audit programme.
  • To report audit findings to the 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 GCP 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 in GCP audit techniques, with 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

Knowledge

  • A Bachelor’s degree in a scientific discipline or nursing degree
  • ICH-GCP international regulations and guidance, with the ability to apply this knowledge to resolve day-to-day issues.

 

Experience

  • Previous GCP auditing experience from working in a Pharmaceutical company or other regulated industry.

 

Skills

  • Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and to work effectively in a multi-disciplinary team.
  • Good organisational skills, with the ability to multi-task, including the ability to work independently or as part of a team, to agreed deadlines.
  • Excellent attention to detail and the ability to identify the root cause of problems.
  • Competency in Microsoft office, Word, Excel, Powerpoint
  • High level of numeracy

 

Desirable Skills

Knowledge

  • Quality Assurance / Quality Management qualifications.
  • GxP international regulations and guidance, with the ability to apply this knowledge to resolve day-to-day issues.
  • European, United States and UK regulatory requirements.
  • Pharmaceutical regulatory standards in clinical research and international regulatory requirements for product registration.

 

Experience

  • GCP auditing experience working in a healthcare company or CRO, with demonstrated knowledge and experience of audit and inspection techniques
  • Experience of auditing Pharmacovigilance activities

 

Skills

  • Competency in use of electronic systems for management and tracking of audits, audit reports, CAPAs.

Location: Cambridge or Field based

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

Clinical Coordination Administrator - Cambridge, UK – 12 month FTC

 

The Role

  • Administration activities in support of the Clinical Coordination Department.

 

Key Responsibilities

  • Administrative support to the Head of Clinical Coordination, and department managers.
  • Emergency Contact Administrator
  • Guideline Administrator
  • Template Administrator
  • Deputise for Librarian
  • Deputise for Archiving Coordinator
  • Purchase order administration
  • Equipment administration
  • Deputise for Office Administrator. 

Essential Skills

  • Previous administrative experience in an office environment
  • Good working knowledge of Microsoft Outlook, Word and Excel.
  • Attention to detail.
  • Ability to prioritise and manage multiple & varied tasks.
  • Good interpersonal skills – including oral and written communication skills.

Desirable

  • Working knowledge of Sharepoint
  • Administrative experience in a clinical research environment 

Location: Cambridge, UK

 

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

Analytical Technician– Batch Release/Stability - Permanent, South East, UK

 

The Role

 

  • To perform the testing and reporting on batch release products according to registered specifications.
  • To perform development and validation of methods, to identify and quantify constituents in extracts and finished products.
  • To ensure that good practices are followed in the Analytical Development/ Stability write-up and laboratory areas and that the areas are maintained in a clean and tidy manner.
  • Training will be provided as necessary
  • Future training opportunities in other techniques. 

 

Key Responsibilities

  • Perform work using techniques such as HPLC, TLC, and Dissolution
  • Ensure Analytical equipment is fully calibrated and serviced in accordance with company procedures.
  • Apply appropriate quality control procedures to all development/ validation protocols and batch release testing to ensure compliance and quality of resulting data.
  • Write, review or update documentation including protocols, SOPs and Test Methods.
  • Write, review or assist team member to write CAPAs, Deviations and OOSs.
  • Check paperwork relating to development, validation and batch release.
  • Maintain all areas of the laboratory in a clean and tidy state.
  • Provide clear and accurate records of all work performed.
  • Report promptly any problems occurring at any phase of a developmental/ validation protocol or during batch release
  • Carry out any other duties as required by the management.
  • The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job. 

Essential Skills

Knowledge/Experience

  • Scientific based degree or an appropriate scientific diploma.
  • Previous laboratory experience. 

Skills

  • Competent in the use of general laboratory instrumentation and devices e.g. pipettes, balances etc.
  • Working knowledge of Excel and Word.
  • Excellent attention to detail and communication skills including written and presentational.
  • Flexibility, as the role will involve assisting the stability team as workload requires.

 

Location: South East, UK

 

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

Analytical Technician– Research and Development - South East UK

 

Permanent

 

The Role

 

 To provide analytical support to the pharmaceutical development department.

 

Key Responsibilities

 

  • To provide analytical support to the pharmaceutical development department, specifically new product pipeline support.
  • To assist in the development of dissolution methods for new capsule formulations.
  • To support the toxicology programmes.
  • To review analytical development protocols and reports.
  • To check completed R&D ARF’s, validation work and any other research data.
  • Where applicable ensure analytical equipment is fully calibrated and serviced in accordance with company protocols and procedures.
  • Maintain all areas of the laboratory in a clean and tidy state.
  • Ensure training records are kept up to date.
  • Carry out any duties as required by the management.
  • The job holder is responsible for maintaining cGXP and H&S knowledge applicable to the job.

 

Essential Skills

 

Knowledge/Experience:

 

  • Scientific based degree or an appropriate scientific diploma and laboratory experience.

Skills:

  • Competent in the use of general laboratory instrumentation and devices e.g. pipettes, balances etc.
  • Working knowledge of Excel and Word.
  • Excellent attention to detail - the job role requires checking of analytical data, reviewing of SOP’s, Test Methods, Protocols and Reports.
  • Good verbal and written communication - the job role requires writing test methods, SOP’s and other GMP documentation. It also requires project work to be presented at the departments R&D team meetings.

 

Location: South East, UK

 

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

Analytical Technician– Stability - South East UK

 

Permanent

 

The Role

 

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

 

Key Responsibilities

 

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

 

Essential Skills

 

Knowledge/Experience:

  • Scientific based degree or an appropriate scientific diploma and laboratory experience.

Skills:

  • Competent in the use of general laboratory instrumentation and devices e.g. pipettes, balances etc.
  • Working knowledge of Excel and Word.
  • Excellent attention to detail - the job role requires checking of analytical data, reviewing of SOP’s, Test Methods, Protocols and Reports.
  • Good verbal and written communication - the job role requires writing test methods, SOP’s and other GMP documentation.

 

Attributes and Behaviours:

  • Is able to work effectively in a team.
  • Adaptability to new techniques and challenges.
  • Able to use own initiative when working on individual projects e.g. background research.
  • Develops and maintains positive working relationships with other colleagues and departments.
  • Ensures a good work ethic and continually shares knowledge and experience.

 

Location: South East UK

 

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

Analytical Scientist - South East, UK

 

Permanent

 

The Role

 

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

 

Key Responsibilities

 

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

Essential Skills 

Knowledge/Experience:

  • Scientific based degree or diploma and laboratory experience
  • Extensive practical experience with HPLC
  • Previous experience with Dissolution Testing
  • Previous experience of QC or Stability Analysis
  • Previous experience of working in a GMP environment Skills:
  • Competent in the use of general laboratory instrumentation and devices e.g. pipettes, balances etc.
  • Working knowledge of Excel and Word
  • Excellent attention to detail - the job role requires checking of analytical data, reviewing of SOP’s, Test Methods, Protocols and Reports
  • Communication skills including written and verbal - the job role requires writing of various analytical documents including Test methods, SOPs and protocols

 Attributes and Behaviours:

  • Is able to work effectively in a team
  • Adaptability to new techniques and challenges
  • Able to use own initiative when working on individual projects e.g. background research
  • Develops and maintains positive working relationships with other colleagues and departments
  • Shares ideas and information
  • Assists colleagues as and when required
  • Demonstrates a ‘can do’ approach 

Desirable

  • Working knowledge of Empower chromatography software system
  • Experience with Pharmacopeial analysis, including wet chemistry methods

 Location: South East, UK

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

Receptionist/Administrator –South East UK

 

Part Time

 

The Role

To provide a professional corporate reception service to all contacts including customers, suppliers, investors and employees and take care of general administrative duties.

 

Hours of work will be 8.30am until 17.00pm Monday and Tuesday and 8.30am until 13.00pm Wednesday. The successful applicant will be expected to provide cover during holiday and sickness periods.

 

Key Responsibilities

  • Reception and management of visitors and deliveries.
  • Effective confidential and courteous handling of telephone enquiries and directing calls to the appropriate staff.
  • Sorting and distribution of all incoming and outgoing post.
  • Administration of confidentiality agreements.
  • Administration of staff holiday forms and Training Folders.
  • Managing and prioritise own work flow.
  • Stock control of stationery requirements.
  • Undertake any other task/duties as may be reasonably required.
  • Responsible for maintaining GCP and H&S knowledge applicable to the job.

 

Essential Skills

Knowledge:

  • Clerical and administrative procedures and systems such as record keeping and filing.

Experience:

  • IT literate with a strong knowledge of Microsoft Office
  • Educated to GCSE level to include English and Maths
  • Experience in a similar role

Skills:

  • Good organisational  and communication skills
  • A good standard of written and spoken English
  • Able to work on own initiative as well as part of a team
  • IT competency - Excel / Word / Power-Point
  • Excellent attention to detail

Attributes and Behaviours:

 

  • Have the ability of prioritising, planning and organising workload.
  • Maintain a positive working environment within the office
  • Demonstrate a “can do” approach.

 

Location: South East UK 

 

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

 

Non Clinical Writer – Cambridge, UK

 

Permanent

 

The Role

Ensuring all nonclinical data is available, identified and appropriately assembled for all Regulatory submissions throughout the product life cycles, including arranging and authoring of nonclinical regulatory documents.

 

Key Responsibilities

These responsibilities include, but are not limited to:

  • Prepare relevant nonclinical sections of documents for Regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), New Drug Applications (NDA), Market Authorisation Applications (MAA), Orphan Drug Applications and Investigator Brochures (IB).
  • Builds Table of Contents (TOC) for nonclinical sections of Regulatory submissions.
  • Maintains an up-to-date knowledge of nonclinical Regulatory guidance to ensure appropriate data are available for Regulatory submissions.
  • Prepares and manages the preparation of nonclinical sections of briefing documents for meetings with Competent Authorities.
  • Prepares nonclinical responses to Competent Authority questions during Regulatory procedures.
  • Coordinates with Regulatory Affairs Department to meet Company timelines and objectives.  
  • Liaise and coordinate with internal personnel, Contract Research Organisations (CROs) and Key Advisors for Regulatory submissions.
  • Contributes to the preparation of SOPs for the Preclinical Department.
  • Coordinates review meetings; prepare amendments as needed, finalised and version-control documents. 
  • Organises QC of required documents and / or sections as appropriate. 

Essential Skills 

  • A graduate degree in a Science/Life Science discipline or another appropriate scientific discipline. 
  • Experience writing and reviewing nonclinical study-related documents within the pharmaceutical, biotechnology and/or contract research organisations.
  • Strong scientific background and excellent nonclinical writing skills
  • Ability to plan and communicate clearly both verbally and in writing
  • Knowledge of GLPs, ICH guidelines and requirements for the successful conduct of nonclinical studies. 
  • Working knowledge of Word, Excel, PowerPoint, Endnote and search engines
  • Excellent communication skills (written and verbal)

Desirable Skills 

  • Ability to QC documents
  • Ability to assimilate and critique scientific writing quickly
  • Able to work within a matrix structure 

Location: Cambridge, UK 

 

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

Pharmacovigilance Administrator – Cambridge, UK

 

Permanent

 

The Role

  • Provides essential administrative support to Pharmacovigilance Department, including accurate data entry of case safety reports.

 

Key Responsibilities

  • Supporting the Pharmacovigilance team with general administrative duties including core filing, scanning of source documentation and contributing to the overall maintenance of Pharmacovigilance systems and processes.
  • Case processing including data entry / case narrative writing from non-serious, post marketing and clinical trial sources onto our global safety database (ARISg), in accordance with company SOPs and regulatory requirements.
  • Performing data entry for a post-marketing registry and assisting with general registry processes.
  • Monitoring / requesting   safety follow up queries from clinical study sites and also from post marketing sources.
  • Assisting with SAE reconciliation / tracking the SAE reconciliation status.
  • Performing additional administrative duties as required by the department.
  • Maintaining a strong GPVP knowledge.

 

Essential Skills

  • Experience of Pharmacovigilance Administration is a pre-requisite and ideally use of a pharmacovigilance database- including case data entry.  
  • Ability to work with others as part of a team.
  •  The candidate will be organised, self-starting and computer literate, with a good working knowledge in the use of Microsoft Excel and Word essential.

 

Knowledge:

  • Knowledge of clerical and administrative procedure and systems such as record keeping and filing.
  • Basic knowledge of the operation of standard office equipment.
  • Knowledge of the relevant company SOP and Guidelines.

 

Skills:

  • Excellent communication skills.
  • Excellent organisational and time management skills.
  • Ability to be proactive, work on own initiative as well as part of a team.

 

Location: Cambridge, UK

 

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

Programme Scheduler – South East, UK

 

Permanent

 

The Role

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

 

Key Responsibilities

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

Essential Skills

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

 

Location: South East, UK 

 

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

Validation Specialist – Cambridge, UK

 

Fixed-Term / Contractor

 

The Role

To perform the duties of CSV specialist for the implementation of an eQMS (QUMAS).

 

Key Responsibilities

  • Provide SME support regarding the validation of the eQMS in a GCP environment following the guidance of GAMP and 21 CFR Part 11.
  • Author deliverables to facilitate the implementation and validation of the chosen eQMS [QUMAS] (Validation Plan, Risk Assessments, Validation Reports). 
  • Preparation and execution of qualification and validation test documentation (IQ, PQ).
  • Writing procedures for the use and management of the QUMAS electronic Quality Management System, in collaboration with user groups and department managers.

 

Essential Skills

  • Knowledge and experience of the principles of GAMP and FDA 21 CFR Part 11.
  • Experience of implementation & validation of an eQMS in a pharmaceutical environment (preferably QUMAS).
  • Good interpersonal skills with a logical and persistent approach to problem solving.
  • Experience of writing and executing validation test documents (IQ, OQ, PQ)
  • Experience of compliance maintenance through documented change management.
  • Highly motivated self-starter, able to organise and push projects forwards.

 

Location: Cambridge, UK

 

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

Discovery Pipeline Administrative Assistant - Cambridge, UK

 

Permanent

 

The Role

  • Primarily, it will be the role of the Discovery Pipeline Administrative Assistant to assist the Discovery Pipeline Team, organise and coordinate the planning record keeping of both non-clinical and clinical projects. You will be required to commute from Cambridge to London regularly.

Key Responsibilities

  • Performing clerical duties/administrative support for the Discovery Pipeline Team.
  • Maintaining the Discovery Pipeline electronic filing structure.
  • Supporting Discovery Pipeline collaborators with invoicing and payment.
  • Charged with monitoring and recording expenditures.
  • Materials Forecasting and ordering from Materials Supply Department.
  • Co-ordination of diaries, meetings, teleconferences.
  • Document Quality Control.
  • Acquisition of literature references for Discovery Pipeline Team via GW Librarian.
  • Document formatting and referencing.
  • Set up and maintenance of The Discovery Pipeline Team’s SharePoint site.
  • Maintaining cGxP and H&S knowledge applicable to the job.
  • Organisation of CDA and legal documents between GW and collaborators.
  • Management of the RAID process.
  • Acts as a conduit between the Pipeline Discovery group and the Preclinical team to facilitate passage of projects through to this group.
  • Monitoring Discovery Pipeline SOPs and Guidelines timelines / expiry dates.

Essential Skills

  • A degree or higher degree (BSc) in Life Sciences
  • Good organisational skills and the ability to prioritise
  • Ability to multitask, use initiative and problem solve
  • Good communication skills
  • Good written and verbal presentation skills
  • Excellent attention to detail
  • Ability to work as a team, and as an individual.
  • Demonstrates a ‘can do’ approach to work
  • Shares ideas and information
  • 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
  • Ability to deliver results within challenging and changing timelines
  • Working knowledge of Excel, Word, PowerPoint, Endnote, search engines and databases used for literature searches.

 

Location: Cambridge, 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:  North Carolina, US 

 

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

Clinical Research Associate – US (various locations)

 

Permanent

 

The Role

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

 

Key Responsibilities

  • Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and Company guidelines.
  • Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
  • In accordance with GW SOPs, performs site management activities including:
    • site evaluation visits
    • site initiation visits
    • monitoring visits
    • 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 – US, various locations 

 

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

 

Senior Product Manager – San Diego, CA

 

Permanent

 

The Role

The individual will be involved in the development, market analysis and implementation of the strategic brand plan for GW’s epilepsy cannabinoid portfolio.  The Senior Product Manager will collaborate with other functional areas, internal groups and external agencies to develop and implement product strategies and tactics that are responsive to customer needs and consistent with market opportunities.

 

Key Responsibilities

  • Development of annual brand plan.  Develop innovative tactics to drive appropriate brand utilization.
  • Oversee market analysis to generate key strategic insights to drive brand direction.
  • Team lead on developing and maintaining a strong customer focus that includes effective working relationships with KOLs and patient organisations.
  • Brand development - develop and maintain branding and core messaging for epilepsy products.
  • Brand lead on digital assets including HCP materials, websites and patient support programs.
  • Develop materials through collaboration with external agencies and internal partners that support the growth of the brand.
  • Build strategic partnerships with cross functional partners and external vendors.
  • Manage budget for accountable projects related to brand
  • Analyse market data and trends to provide detailed recommendations
  • Develop and execute against promotional strategy and tactical plans 

Essential Skills

  • Bachelor’s degree in related field, MBA an advantage
  • Extensive  pharmaceutical experience in sales, sales management, and marketing areas, with brand management experience
  • Strong knowledge of pharmaceutical marketing areas including product positioning, brand plan development, and launch planning
  • Neurology/CNS experience with a focus in Epilepsy an advantage
  • Experience in managing multiple projects and vendors
  • Proven leadership abilities working within a cross-functional team
  • Proven and demonstrated experience creating and presenting strategic business plans
  • Excellent communication, presentation and time management skills required
  • Must be adaptable and able to relate effectively with people at all organisation levels
  • Available for overnight travel within the US

 

Location: San Diego, CA

 

To apply please send your CV with salary expectations to usrecruitment@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 – IMP returns specialist – US

 

Permanent

 

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 Trial Supplies Programme Manager - US

 

Permanent

 

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.