Manager Medical Writing

3 weeks ago


london, United Kingdom The RFT Group Full time

Medical Writing Manager Our client is a Biotech company with a strong pipeline, now wish to hire a Medical Writing Manager working closely with functional teams e.g. Regulatory Affairs, Medical Writing, Clinical Operations, Medical Affairs, etc. The successful candidate will author, review and manage clinical documents, e.g., clinical study protocols and/or amendments, investigator brochures, clinical study reports and clinical summaries, and regulatory development documents for FDA, EMA, MHRA, etc. This hire will be work remotely from their own home office in the UK (must be resident there, with work authorisation), with occasional travel to their HQ office. The ideal candidate will be experienced in preparing, coordinating and managing Regulatory Submissions of clinical documents and writing clinical components for regulatory filings (NDA, BLA, MAA) within Pharma / Biotech environment. Requirements include: BSc in Life Sciences. Advanced Qualifications preferred i.e. PhD and Post Doctorate work. 8+ years Pharma / Biotech industry experience, 3 years of authoring, writing or editing of clinical documents for regulatory filings / submissions i.e. NDA, BLA, MAA within Pharma / Biotech environment. In-depth of knowledge writing or editing clinical trial documents, e.g., Protocols, IBs, CSRs and clinical summaries to ICH GCP and regulatory requirements. Strong analytical skills including good understanding of common statistical methods used in clinical trials and interpretation of their results. High quality standards and is committed to meet deadlines. Excellent written and oral communication skill within medical/science area. Solid ability to perform background literature research. Excellent English (written and spoken). Excellent attention to detail. For further details, please contact Larry on +353 1 – / The RFT Group , BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. Follow us on Twitter, Facebook and LinkedIn



  • London, Greater London, United Kingdom Syneos Health Full time £60,000 - £110,000 per year

    DescriptionManager, Medical Writing - RegulatorySyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to...


  • London, United Kingdom Ipsen Full time

    Job DescriptionJob Title: Sr. Manager Medical WritingDivision / Function: Medical Writing (Global Clinical Development Operations)Location:London (Primary Location); US (Secondary)WHAT - Summary & Purpose Of The PositionThe Sr. Manager, Medical Writing is a strategic and operational leader responsible for overseeing the planning, development, and delivery of...


  • London, United Kingdom Ipsen Full time

    Job Title: Sr. Manager Medical WritingDivision / Function: Medical Writing (Global Clinical Development Operations)Location:London (Primary Location); US (Secondary)WHAT - Summary & Purpose Of The PositionThe Sr. Manager, Medical Writing is a strategic and operational leader responsible for overseeing the planning, development, and delivery of high-quality...


  • London, United Kingdom Ipsen Full time

    Job Title: Sr. Manager Medical WritingDivision / Function: Medical Writing (Global Clinical Development Operations)Location:London (Primary Location); US (Secondary)WHAT - Summary & Purpose Of The PositionThe Sr. Manager, Medical Writing is a strategic and operational leader responsible for overseeing the planning, development, and delivery of high-quality...


  • London, United Kingdom Ipsen Full time

    Job Title: Sr. Manager Medical WritingDivision / Function: Medical Writing (Global Clinical Development Operations)Location:London (Primary Location); US (Secondary)WHAT - Summary & Purpose Of The PositionThe Sr. Manager, Medical Writing is a strategic and operational leader responsible for overseeing the planning, development, and delivery of high-quality...


  • City Of London, United Kingdom Ipsen Full time

    Join to apply for the Senior Manager Medical Writing role at IpsenJob Title: Sr. Manager Medical WritingDivision / Function: Medical Writing (Global Clinical Development Operations)Location: London (Primary Location); US (Secondary)Summary & Purpose Of The PositionThe Sr. Manager, Medical Writing is a strategic and operational leader responsible for...


  • City Of London, United Kingdom Ipsen Group Full time

    Cookie Notice**Title:**Senior Manager Medical Writing**Company:**Ipsen Biopharm Ltd**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and...


  • Greater London, United Kingdom Syneos Health Full time

    Manager, Medical Writing - Regulatory Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...


  • London, United Kingdom Cpl Life Sciences Full time

    Director of Medical Writing London Salary details are available upon request. Please also note that this role can be fully remote based within the UK. Our client is a Global CRO who are looking to appoint a Director of Medical Writing to join their growing Communications team. In this strategic leadership position, youll work closely with colleagues in the...


  • London, United Kingdom EVERSANA Full time

    Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help...