Director, Medical Writing

Location
San Francisco, California
Posted
Apr 20, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Description

The Director, Medical Writing will be responsible for writing various clinical and regulatory documents including distribution of work to contract medical writers or agencies as needed. The position’s focus includes protocol development, clinical study report and regulatory submissions, as well as scientific manuscripts and abstracts. The successful candidate will work closely with cross-functional teams to ensure the documents are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines and eCTD requirements.  The Director, Medical Writing will report to the Vice President of Development Operations.

Responsibilities:

  • Write, edit, or collaborate on development of high-quality clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
  • Contribute scientifically and strategically and lead submission-level activities for writing team
  • Ensure smooth and effective document management from start to finish (i.e. from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (i.e. reviews, QC, QA, formatting, publishing, document archiving)
  • Assist in the analysis, synthesis and presentation of complex information for scientific presentations
  • Distill large amounts of clinical and scientific data into essential elements for graphical display
  • Draft manuscripts, abstracts and posters for submission to medical journals and/or scientific meetings
  • May interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses.
  • Formulate key messages from clinical study data
  • Perform literature-based research to support writing activities
  • Develop and maintain medical writing processes, SOPs, templates and outlines for key documents
  • Write summaries and maintain files on informative medical and scientific journal articles

Qualifications:

  • BS, MS, or PhD in a scientific or medical discipline
  • Twelve years’ experience with medical/regulatory/publication writing and editing
  • Experience authoring/editing CSRs and other types of clinical regulatory documents (i.e. clinical protocols, Investigator’s Brochures, NDA modules) or scientific publications
  • Proven expertise in implementing medical writing processes and standards
  • Expert abilities in Microsoft Office Suite, Adobe Acrobat and electronic content management systems
  • In-depth understanding of regulatory/ICH guidelines and GCPs, Good Publication Practices (GPP) and related standards (i.e. CONSORT, ICMJE) and clinical trial transparency requirements (i.e. EudraCT, CT.gov)
  • Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
  • Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects