Associate Director, Quality Control, Data and Regulatory Expert
4 weeks ago
At Cpl Life Sciences, we are seeking an experienced Associate Director to lead our medical writing activities for our Oncology innovation within Radiopharmaceuticals. As a key member of our team, you will be responsible for planning, developing, and writing clinical and regulatory documents to support medical and regulatory activities across our portfolio.
Key Responsibilities:- Lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
- Apply expert medical writing proficiency to ensure that scientifically robust messages and arguments are developed and conveyed consistently across documents.
- Support medical writing activities across all stages of drug development, including planning and authoring stages across all document types and regulatory submissions.
- 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.
- At minimum a degree in life sciences and at least 10 years of medical or regulatory/clinical writing experience, in the pharmaceutical industry.
- 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.
We offer a competitive salary and package, as well as the opportunity to work on innovative Radiopharmaceuticals projects. If you are a motivated and experienced medical writer looking to take on a leadership role, we encourage you to apply for this exciting opportunity.
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Oxford, Oxfordshire, United Kingdom Cpl Life Sciences Full timeMedical Writing Job Type: Permanent, full-timeLocation: Oxford, UK – Hybrid/RemoteAttractive salary and packageAn exciting opportunity for an experienced Medical Writer to join a growing biotechnology company at the forefront of Oncology innovation within Radiopharmaceuticals.As an Associate Director, Medical Writing, you will oversee all medical writing...
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