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Director – head of medical writing

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This is a Full-time position in South San Francisco, CA posted December 20, 2019.

The Director, Medical Writing will be responsible for writing various clinical and regulatory documents including distributing work with contractors or agencies as needed.

The position’s focus includes protocol development, clinical study reports and regulatory submissions.

Successful candidates must work well with cross-funcional teams to ensure documents are of high quality and compliant with SOPs, ICH/GCP/regulatory guidelines and eCTD requirements.

This position will report to the Exec Director of Clinical Development.

Salaries are very competitive for this opportunity!

Role Responsibilities Manage the writing, editing, or collaborating on development of high-quality clinical/regulatory documents (Protocols, IB’s, CSR’s, INDs, eCTD/NDA clinical summaries, briefing books.) Contribute scientifically and strategically and lead submission-level activities for writing team Manage documentation process (i.e.

from template to a final approved version), and also managing various processes (i.e.

reviews, QC, QA, formatting) Requirements 8-12+ years of experience with medical/regulatory writing and editing Experience authoring/editing CSRs and other types of clinical regulatory documents such as clinical protocols, Investigator’s Brochures, NDA modules.

If interested, please feel free to reply directly to steven@peoplewithchemistry.com There is also an Associate Director level position available with more writing responsibilities.