Overview

The Senior Manager/Associate Director, Medical Writing will be responsible for writing and overseeing the writing of various clinical and regulatory documents.

The Senior Manager, Medical Writing 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 company goals. The core duties of the Sr Manager, Medical Writing are delineated below.

Work Model

Remote: officially documented as working full time from home, with travel to the company’s offices or other locations on occasion as needed.

Responsibilities

  • Write, edit, or collaborate on the development of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
  • 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 (e.g., reviews, QC, QA, formatting, publishing, document archiving)
  • Review, edit, and ensure the quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards
  • Distill large amounts of clinical and scientific data into essential elements for graphical display
  • Oversee document review and comment resolution meetings with cross-functional teams
  • Formulate key messages from clinical study data
  • Perform literature-based research to support writing activities
  • Develop best practices for authoring and reviewing
  • Develop and maintain templates and outlines for key documents

Requirements

  • BS, MS, or doctorate in a scientific or medical field
  • 5+ years in the biotechnology/pharmaceutical industry preferred
  • In-house experience preferred
  • Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus.
  • Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
  • Proven ability to develop and implement medical writing processes and standards
  • Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues
  • Rare disease experience a plus

The following are some highlighted benefits, but not limited to:

  • Summer and Winter shutdown in addition to generous vacation benefit and many observed company holidays
  • Long-term Incentive and Employee Stock Purchase Plans
  • Paid parental, adoption, and caregiver leave
  • Wellness Offering
  • Deferred compensation for specific roles
  • Fitness reimbursement
  • Tuition Reimbursement
  • Professional development programs