Senior Medical Writer - PBRER, DSUR, Protocol
Posted Today by Hays Life Sciences
£75 Per hour
Outside
Remote
City of London, London
Summary: The Senior Medical Writer will lead the authorship of regulatory documents and manage submissions to regulatory agencies for a global biopharmaceutical company. This role requires expertise in scientific writing, particularly in the areas of Oncology, neurology, rare diseases, ophthalmology, and immunology. The position is remote and classified as outside IR35, offering a competitive hourly rate. Candidates must possess a relevant life sciences degree and extensive experience in regulatory scientific writing.
Key Responsibilities:
- Lead author on regulatory documents and manage submissions to regulatory agencies.
- Ensure documents are clearly written, accurate, and consistent with regulatory guidelines.
- Write protocols, PBRERs, DSURs, and medical device documentation.
- Maintain familiarity with drug and device development processes and regulations.
- Utilize administrative and project planning skills effectively.
Key Skills:
- University degree in a life science.
- Several years of experience in scientific writing and editing in a regulatory domain.
- Hands-on writing experience with protocols, PBRERs, DSURs, and medical devices documentation.
- Knowledge of GxP, GCP, ICH, ISO, MDR/IVDR regulations.
- Proficiency in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault.
- Fluent in English, both verbal and written.
Salary (Rate): £75.00/hour
City: City of London
Country: UK
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: Senior
Industry: Other
Your new company My client is a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people's quality of life, specialising in Oncology, neurology, rare diseases, ophthalmology and immunology. There is an opportunity for a Senior Medical Writer to join their team.
Outside IR35
Remote UK
Your new role As a highly motivated individual, your primary responsibility as a Senior Medical Writer will be to be the lead author on documents and manage the submission of regulatory content to regulatory agencies, including the Clinical Dossier and/or Suite of Safety reports for drugs or medical devices.
With your scientific writing capabilities, you will ensure that the documents are clearly written, accurate and consistent and adhere to the company's and applicable regulatory guidelines/SOPs.
What you'll need to succeed Hold a university degree in a life science. Have several years of working experience in scientific writing and editing in a regulatory domain, ideally within Pharma. Must have hands-on writing experience of protocols, PBRERs, DSURs etc and experience with Medical Devices documentation. Familiar with regional/global drug and device development processes, regulations, and guidelines (e.g., GxP, GCP, ICH, ISO, and MDR/IVDR) and an understanding of GVP and GCP principles, including data integrity. Excellent administrative and project planning skills, with proficiency in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault; detail-oriented, creative thinker with a curiosity to learn and adapt to change, and fluent in English (verbal and written).
What you need to do now Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and living in the UK. If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed)