Medical Writer (Rest of World)

Greenwich Biosciences, Inc ,
London, Greater London
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Job Description

ABOUT GW: GW Pharmaceuticals (GW), along with its U.S. subsidiary Greenwich Biosciences, is a pioneering global biopharmaceutical company that has established a world-leading position in cannabinoid science and medicines. GW's mission is to transform the lives of seriously ill patients through developing and delivering rigorously tested cannabis-derived pharmaceutical medicines. Our medicines have documented safety and efficacy profiles, are approved by regulators and are manufactured to the highest standards. GW's research efforts initially focused on the unmet needs of patients with Multiple Sclerosis (MS), while in recent years the Company has focused on helping children and adults with severe, life threatening forms of epilepsy. Looking to the future, GW's deep scientific knowledge and extensive body of research is enabling the Company to explore new therapeutic areas including neurology, oncology, psychiatry and autism spectrum disorders. In 2018, TIME magazine named GW one of the 'Top 50 Genius Companies of 2018 That Are Inventing the Future'. We are looking for talented individuals who are passionate about making a difference in the lives of our patients. GW Pharmaceuticals, PLC is based in the UK. We have sites in London, Cambridge, Kent and Andover. Our U.S. subsidiary, Greenwich Biosciences, is located in Carlsbad, California. JOB PURPOSE: To undertake various medical writing and quality control activates for global submissions. KEY RESPONSIBILITIES/ACCOUNTABILITIES * Complete medical writing activities related to global submissions to appropriate quality standards and required timelines. * Undertake quality control checks on company documentation as requested, to required timeline * Maintains GCP and Health & Safety knowledge as applicable to the job. DETAILED RESPONSIBILITIES/ACCOUNTABILITIES Writes/updates, formats, reviews, or QC checks the following essential documents for global submissions: * Documents contained in the modules of the Common Technical Document (CTD) * Briefing books * Response to health authority questions * Conducts literature reviews and summarises relevant information. * Writes, prepares and/or QC checks other clinical documentation, as applicable. * Is responsible for ensuring up-to-date with company SOPs, relevant regulations and legislation and to ensure that company documentation meets with these standards. * 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. KEY ATTRIBUTES/SKILLS/EDUCATION - ESSENTIAL Experience: * Scientific graduate; PhD in Biomedical Sciences desirable, with experience in the clinical research environment * Experience in preparing marketing applications for global health authorities, including adapting core dossiers for specific regions Knowledge: * Good knowledge of relevant regulations and legislation. Skills: * Excellent written English with ability to interpret data and express findings in a clear and concise manner. * Excellent attention to detail. * Excellent organisational and time management skills. * Excellent communication skills including ability to work with colleagues across all clinical development functions. * Comprehensive computational skills, particularly in the use of Microsoft packages. Attributes and Behaviours: * Ability to be proactive, to work on own initiative and as part of a team. * Flexibility in meeting challenging deadlines and changing requirements. * Develops and maintains positive working relationships with others. * Shares ideas and information. * Assists colleagues as and when required. * Demonstrates a 'can do' approach. KEY ATTRIBUTES/SKILLS/EDUCATION - DESIRABLE: Medical background enabling, for example, enhanced interpretation and understanding of laboratory results, clinical findings, drug interactions etc. GW's VISION: Unlock the potential of cannabinoid science to transform the lives of the patients and their families GW's MISSION: Lead the world in developing and commercialising regulatory approved cannabinoid medicines, putting patients first Our efforts are guided by several fundamental values. At all times we strive to be: Patient Driven - We never forget who we're striving for Passionate - We are here to change lives Innovative - We challenge ourselves to find new and better approaches Collaborative - We accomplish more through working together and valuing one another Accountable - We take responsibility and deliver on our commitments Integrity - We are fair, honest, and ethical Excellence - We pursue the highest standards for ourselves and for our industry Join Us! Important notice to Employment businesses/ Agencies GW Pharmaceuticals ("GW") does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GW's Talent Acquisition department to obtain p

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