Senior Manager, Medical Writing

🕒 July 22

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

✏️ Content Writer

👻 Ghost score 23%

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• Provide leadership and management of 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, and 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

🎯 Requirements

• 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 therapeutics areas and phases of clinical studies • 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

• Health insurance • Retirement plans • Flexible work arrangements • Paid time off • Professional development