Director, Medical Writing
San Diego, CA, USA | Leading Non-Profit / Social Enterprise Company
Industry:Non-Profit / Social Enterprise
Job Description:74 people have viewed this job
Leads and directs the medical writing activities to support INDs/BLAs across research and clinical programs ensuring appropriate resources are in place to support all medical writing needs to deliver documents within established timelines and budget.
Establishes the operational standards for the medical writing activities (e.g. style guidelines, templates and QC, etc.)
Produces high-quality documents to meet aggressive timelines, ensuring consistent messaging across appropriate documents (nonclinical, clinical, and product labeling)
Is aware of and understands the regulatory guidance’s regarding content for various clinical/regulatory documents and can apply this knowledge to the development of submission documents.
Manage the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
Lead the writing, editing, QC (technical editing) activities for assigned projects.
Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
Contribute to statistical output plan concerning organization and table layout for a specific document.
Actively supports clinical project teams, representing Medical Writing and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary.
Ensure that medical writing activities are coordinated with other departments, including Clinical Operations, Pharmacovigilance, Regulatory and other groups.
Education and Experience
’s degree in science with relevant writing experience OR ’s degree in English or Communications with significant relevant scientific experience; , PharmD OR ’s degree highly preferred.
3-5 of relevant pharmaceutical and/or medical device industry experience, with at least 3 of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/BLA/NDA sections).
Strong working knowledge of Adobe PDF, WORD, EXCEL, PowerPoint, and Project.
Experience with automated document templates and style guides.
Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures.