Job Description

This role will serve as an expert Medical Writer who is responsible for planning, developing, and writing clinical 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.

Responsibilities

• Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
• Serve as a document planning and writing expert; responsible for guiding a medical writing and project team during the 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.
• Lead, and actively contribute to, the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance as applicable. Own relevant medical writing processes; lead medical writing SOP creation/update initiatives.
• 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.

Requirements

• PhD degree in life sciences, biological science preferred.
• Experience in in the pharmaceutical industry. Oncology and immunology experience highly preferred.
• At least 10 years’ medical or scientific writing experience.
• Extensive experience writing protocols, clinical study reports, experience authoring clinical components in regulatory filings (NDA, BLA, MAA).
• Expert understanding and knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents, 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.
• Work collaboratively and lead cross-functional teams
• Good interpersonal and ownership.
• Hybrid Working.

Job Tags

Similar Jobs