Remote Senior Manager, Medical Writing & Regulatory

UBC; Idaho; On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities for promotion

401K with company match*

Flexible work environment

Discretionary PTO (Paid Time Off) OR 0

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Job summary

UBC seeks a Sr. Manager Medical Writing to lead a team of medical writers and deliver regulatory and scientific documents across phases I–IV and post-marketing.

This remote US role requires strong leadership, project management, and expert knowledge of medical terminology and regulatory writing processes. You will collaborate across departments (SERRM, Data Management, Biostatistics, QA) to ensure timely, high-quality documents within budget, while mentoring staff and driving process

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 therapeutics 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.

Responsibilities

• 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.

Skills

Leadership

Communication skills

Interpersonal skills

Attention to detail

Analytical skills

Project management

Medical terminology knowledge

Education

Biological sciences master/PhD

Tools

Microsoft Word

Adobe Pro

Job description

UBC seeks a Sr. Manager Medical Writing to lead a team of medical writers and deliver regulatory and scientific documents across phases I–IV and post-marketing.

This remote US role requires strong leadership, project management, and expert knowledge of medical terminology and regulatory writing processes. You will collaborate across departments (SERRM, Data Management, Biostatistics, QA) to ensure timely, high-quality documents within budget, while mentoring staff and driving process