[Hiring] Senior Manager, Medical Writing @United Biosource Corporation

Role Description

This position will manage a team of medical writers and consult on and compose scientific, educational, research, and regulatory documents for Medical Writing client projects. Responsibilities include:

• Provide leadership and management of the Medical Writing group.
• Lead programs and prepare Phase 1 through IV and post-marketing regulatory documents including:
  • Clinical protocols and study reports
  • Study synopses
  • IND, NDA, and MAA submission documents
  • Safety narratives
  • Registry and observational study protocols and reports
  • Risk evaluation and mitigation strategy (REMS) assessment reports
  • Knowledge, attitude, and behavior surveys (KABS) reports
  • Abstracts/manuscripts for publication
• Ensure peer review and QC of regulatory documents for publishing according to standard operating procedures (SOPs).
• Participate in UBC and client project teams for project planning and development of timelines.
• Coordinate/consult with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects.
• Lead preparation and review of departmental standard operating procedures (SOPs) to improve efficiencies and quality of processes.
• Participate in requests for information (RFIs) and requests for proposals (RFPs) for business development opportunities.

Qualifications

• Master's or doctorate degree in biological sciences or equivalent
• 10-15 years of experience with at least 8 years’ experience in medical regulatory writing or equivalent within the pharmaceutical/CRO industry
• Wide breadth of experience in multiple therapeutic areas and phases of clinical studies
• Leadership experience of a medical writing team
• Advanced word processing skills (Microsoft Word) and advanced Adobe Pro skills
• Familiarity with different document management systems
• Knowledge of medical terminology and understanding of the clinical trial process
• Knowledge of REMS and KAB regulatory programs preferred
• Ability to interpret clinical data and strong analytical skills to communicate to cross-functional teams
• Strong leadership and organizational skills
• Attention to detail/high degree of accuracy
• Strong communication and interpersonal skills

Requirements

• Supervisory Responsibility: Team of medical writers (between 4-10 resources)