Senior Medical Writing Lead
2 weeks ago
Cpl Healthcare is seeking a highly experienced Senior Medical Writing Lead to join our team. As a key member of our Medical Writing department, you will be responsible for leading the planning and authoring of complex clinical and regulatory documents to support medical and regulatory activities across our portfolio.
Key Responsibilities:
- Apply expert medical writing proficiency to lead the planning and authoring of complex clinical and regulatory documents and submission packages.
- Support medical writing activities across all stages of drug development.
- Plan and author 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.
Requirements:
- At minimum a degree in life sciences and at least 10 years' 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).
- 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 finalize 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.
- Capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines.
This is a unique opportunity for a highly experienced medical writer to take on a leadership role and drive the development of our medical writing department.
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