Director, Medical Writing

San Diego, CA or Remote

  • Biosplice is seeking a responsible, dynamic, creative, and highly motivated Director of Medical Writing executing on medical writing deliverables including clinical, preclinical, non-clinical toxicology, and CMC documents for global regulatory submissions, clinical protocols and study reports, investigator brochures, pediatric investigational plans, clinical trial results postings (ClinicalTrials.gov), and other key clinical and regulatory documents.

Specific Responsibilities

  • Implements direction, strategy, and performance standards for the medical writing team, as well as mentors and develops employees to expand employee performance levels
  • Manages medical writing tracker to ensure proper planning and prioritization of medical writing activities
  • Works directly to support the clinical, non-clinical, and regulatory teams
  • Oversees proposals, selection, and management of CROs and other vendors
  • Manages the document review process, route documents for approval
  • Coordinates with project team leads for content, source documents
  • Participates in project team meetings to provide input regarding deliverables, timelines, and processes
  • Formats and manages long documents with multiple review cycles and tight deadlines
  • Reviews analyses for accuracy and consistency
  • Provide support for QC of complex clinical documents
  • Manages development of process improvement tools for Medical Writing and SOP development
  • Review and update style guide to ensure consistency across documents
  • Documents include but are not limited to: Module 2 nonclinical written and tabulated summaries, Protocols and protocol amendments, clinical study reports, Investigator brochures, annual reports and submission documents, pharmacology, PK reports, briefing documents, and regulatory responses
  • Oversee, and potentially contribute directly to, the development of publications/presentations of emerging clinical data for Congresses, and/or other external stakeholders
  • Oversee, and potentially contribute directly to, the development of manuscripts summarizing the emerging clinical data
  • Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents
  • Ensure that the key messages in protocols, publications, presentations, and regulatory documents align with each other, and also with the Investor Relations documents

Requirements

  • Minimum MS/MA. Advanced degree preferred, preferably in a scientific discipline
  • MS/MA with 5+ years’ experience or PhD with 3+ years’ experience working as a Medical Writer in a pharmaceutical or Biotechnology industry, preferably in musculoskeletal and oncology
  • Experience and knowledge in the preparation documentation supporting global regulatory submissions. Experience with marketing applications (NDA/BLA/MAA) is a plus, but not required
  • Ability to understand and interpret clinical and scientific data
  • Knowledge and understanding of applicable US and global regulations and guidances
  • Knowledge of eCTD content/format requirements
  • Ability to influence
  • Excellent verbal and written communication skills
  • Strong organizational skills

Please submit your resume or additional inquiries to apply@biosplice.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.