Sr. Manager, Medical Writing

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Sr. Manager, Medical Writing

Regular Research & Clinical Remote, US

7 days ago Requisition ID: 7547

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improvingpatient outcomes and advancing healthcare.At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impacton the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

Job Title:Sr. Manager Medical Writing

Brief Description: This position will manage team of medical writers and consult on and compose scientific, educational, research and regulatory documents for Medical Writing client projects. Break down complex concepts and medical terminology and write for the level of understanding for the specific target audience. Lead teams and manage projects to deliver quality documents on time with excellent quality and within department budget.

Specific job duties:

• 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.

Supervisory Responsibility:

Team of medical writers (between 4-10 resources)

Desired Skills and 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

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

• Remote opportunities
• Growth opportunities for promotion
• 401K with company match*
• Flexible work environment
• Discretionary PTO (Paid Time Off) 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

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.