[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 and communicate to cross-functional teams.
• Strong leadership and organizational skills.
• Attention to detail/high degree of accuracy.
• Strong communication and interpersonal skills.

Benefits

• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*
• Tuition reimbursement
• Flexible work environment
• Discretionary PTO (Paid Time Off) OR 20 days PTO
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs