Job Title: Associate Director, Medical Writing
Job Type: Permanent, full-time
Location: Oxford, UK – Hybrid/Remote
Remuneration: Attractive salary and package
An exciting and rare opportunity for an experienced Medical Writer to join a growing biotechnology company who are at the forefront of Oncology innovation within Radiopharmaceuticals.
As an Associate Director, Medical Writing you will have oversight of all medical writing activities and serve as an expert Medical Writer who is responsible for planning, developing, and writing clinical and regulatory documents to support medical and regulatory activities across the portfolio by ensuring that scientifically robust messages and arguments are developed and conveyed consistently across documents. Ideally, you will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.
Job responsibilities:
- Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
- Confident with the development of the following documents, including, but not limited to: clinical trial outlines, clinical trial protocols/amendments, Clinical/Non-clinical 2.4, 2.5, 2.6, 2.7 CTD modules, investigators brochures, PIPs, DSURs, CSRs, Health Authority briefing books, clinical submission documents, and other clinical documentation to support the conduct of the clinical trials and regulatory submissions/filings.
- Serve as a document or process subject matter expert, leading cross-functional and cross-department process improvement initiatives.
- Supporting medical writing activities across all stages of drug development.
- Planning and authoring stages across all document types and regulatory submissions, including facilitating document contributor/review meetings, developing and managing timelines, coordinating document review, and driving decision-making.
- Initiate and drive strategic medical writing initiatives and processes with high technical acumen to ensure execution on company priorities.
- May be responsible for managing the oversight of medical writing vendors/CROs, ensuring high-performance standards are met.
- Proactively lead and/or engage in department activities and serve as a mentor for junior writers.
- Actively provide input to the overall strategy, unified objectives, and areas for development of the Medical Writing department.
Job Requirements:
At minimum a degree in life sciences and at least 10 years of medical or regulatory/clinical writing experience, in the pharmaceutical industry. Oncology experience is highly preferred.
- Extensive experience writing protocols, investigator’s brochures, clinical study reports, Health Authority briefing packages, Health Authority responses, and Paediatric Investigational Plans (PIPs). Experience authoring clinical components in regulatory filings (NDA, BLA, MAA).
- Expert understanding and knowledge of regulatory requirements and drug development processes, regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports), CTA/IND/HA regulatory submissions, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
- Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
- Independently prepare edit, and finalise complex, strategic clinical and regulatory documents, including clinical trial protocols/amendments, investigator’s brochures, clinical study reports, PIPs, Health authority briefing packages, Health Authority responses, and clinical CTD submission documents.
- You are capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines.
- You are motivated and detail-oriented.
- You have the ability to work across all trial phases and prioritise your own tasks.
- You are proactive and open-minded.
This is a perfect opportunity for a Principal Medical Writer to step into an Associate Director position and take the lead on all medical writing activities for innovative Radiopharmaceuticals.
For more information about this position please reach out to lucy.kirkaldy@cpl.com
Please note you MUST have the right to work in the UK without any restrictions.
