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ProPharma Group
,
Seer Green, Buckinghamshire
Medical Writer - Regulatory (REF5663W)
Overview
Job Description
Company Description Southwood Research, a ProPharma Group company, is a leading provider of pre-approval regulatory science services to the pharmaceutical and biotech industries. ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes. Job Description A Medical Writer will author regulatory, clinical trail and medical affairs documentation. Additionally, the Medical Writer will contribute to medical writing knowledge to new business proposals. Essential Functions Include: * High quality regulatory writing including authoring clinical summaries, briefing documents and Paediatric Investigation Plans for EMEA submissions. * Represent Medical Writing on project teams and, as such, advise teams and clients on content and format requirements for various documents, as well as coordinate writing activities for document development. * Ensure compliance, remain informed on regulations and developments in medical writing. * Maintain knowledge of product areas, current trends, and current literature. * Providing general scientific insight for new business pitches and proposals. Qualifications Qualified candidates must have: * Post graduate degree in a life sciences discipline * Regulatory and EMEA submission experience * Good working knowledge of the healthcare and pharmaceutical industry * Oncology, haematology, orphan diseases and immunology experience preferred * Excellent interpersonal skills * Keen attention to detail * Flexibility to move quickly between projects and work across different therapy areas * A positive can-do attitude * Ability to work independently but contribute pro-actively to a project team Additional Information All candidates must be legally eligible to work in the United Kingdom. Full time role with the opportunity to work remotely, with occasional travel into the office. Candidates can be based in the UK or the Netherlands. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Qualifications: Qualified candidates must have: Post graduate degree in a life sciences discipline Regulatory and EMEA submission experience Good working knowledge of the healthcare and pharmaceutical industry Oncology, haematology, orphan diseases and immunology experience preferred Excellent interpersonal skills Keen attention to detail Flexibility to move quickly between projects and work across different therapy areas A positive can-do attitude Ability to work independently but contribute pro-actively to a project team Responsibilities: A Medical Writer will author regulatory, clinical trail and medical affairs documentation. Additionally, the Medical Writer will contribute to medical writing knowledge to new business proposals. Essential Functions Include: High quality regulatory writing including authoring clinical summaries, briefing documents and Paediatric Investigation Plans for EMEA submissions. Represent Medical Writing on project teams and, as such, advise teams and clients on content and format requirements for various documents, as well as coordinate writing activities for document development. Ensure compliance, remain informed on regulations and developments in medical writing. Maintain knowledge of product areas, current trends, and current literature. Providing general scientific insight for new business pitches and proposals.