Senior Medical Writing Manager — Lead Regulatory Docs (Remote)

United Biosource Corporation; United States; Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities for promotion

401K with company match

Flexible work environment

Discretionary PTO or 20 days PTO

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

United Biosource Corporation is seeking a Sr. Manager of Medical Writing to lead a team of medical writers and to oversee the creation of regulatory and educational documents for client projects.

You will translate complex medical concepts for diverse audiences and ensure timely, high-quality deliverables. The role requires supervising a 4–10 person team, coordinating with multiple departments, and shaping SOPs to improve efficiency and document quality.

Qualifications

• Master's or doctoral degree in biological sciences or equivalent.
• 10–15 years of experience with at least 8 years of medical regulatory writing experience in pharma/CRO.
• Leadership of a medical writing team across multiple therapeutics and study phases.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Provide leadership and management of Medical Writing group.
• Lead programs and prepare regulatory documents including protocols, study reports, INDs, NDA/MAA, safety narratives and publications.
• Ensure peer review and QC of regulatory documents per SOPs.
• Coordinate with client teams and other UBC departments on project timelines.
• Lead development of SOPs to improve efficiency and quality.
• Support business development through RFIs/RFPs.

Skills

Leadership

Medical Writing

Regulatory Writing

Project Management

Cross-functional Collaboration

Communication

Mentoring

Attention to Detail

Microsoft Word

Adobe Pro

REMS/KAB Knowledge

Education

Master's or Doctorate in Biological Sciences

Tools

Microsoft Word

Adobe Pro

Document Management Systems

Job description

United Biosource Corporation is seeking a Sr. Manager of Medical Writing to lead a team of medical writers and to oversee the creation of regulatory and educational documents for client projects.

You will translate complex medical concepts for diverse audiences and ensure timely, high-quality deliverables. The role requires supervising a 4–10 person team, coordinating with multiple departments, and shaping SOPs to improve efficiency and document quality.