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As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient 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 impact on 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.
If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!
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
Benefits:
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
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
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.
