United BioSource Corporation

Sr. Manager, Medical Writing

United BioSource Corporation • $120K — $145K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Master's or doctorate in biological sciences or equivalent required.
  • 10-15 years of experience in medical regulatory writing within the pharmaceutical or CRO industry mandatory.
  • At least 8 years of experience specifically in medical writing is needed.
  • Proven leadership experience managing a medical writing team is essential.
  • Familiarity with REMS and KAB regulatory programs preferred for candidates seeking an edge.

Responsibilities

  • Manage and lead a team of medical writers effectively.
  • Develop and prepare regulatory documents for clinical trials from Phase 1 through IV and post-marketing.
  • Ensure quality and compliance of documents through peer review and standard operating procedures (SOPs).
  • Collaborate on project planning with UBC and client teams to establish timelines.
  • Consult with various departments to enhance project outcomes and deliverables.
  • Drive the improvement of departmental SOPs for efficient and quality processes.
  • Engage in business development tasks, including preparation for RFIs and RFPs.

Benefits

  • Opportunity to lead and shape a team of skilled professionals in medical writing.
  • Collaboration across various departments enhancing cross-functional exposure.
  • Impactful work that contributes to critical regulatory submissions and healthcare outcomes.
Full Job Description
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

About United BioSource Corporation

United BioSource Corporation is a leading provider of healthcare services and solutions. The company specializes in providing support for clinical trials, patient access programs, and post-approval research, helping pharmaceutical and biotech companies to bring new treatments to market more quickly and effectively. United BioSource Corporation has a global presence, with operations in North America, Europe, and Asia, and a team of over 1,500 professionals with expertise in a wide range of therapeutic areas. The company is committed to improving patient outcomes and advancing the field of healthcare through innovative solutions and collaborative partnerships.
Learn more about United BioSource Corporation
Size
1,500 employees
Industry
Healthcare
Net Income
$20 million
Founded
2003
5 Year Trend
+10%
Revenue
$300 million
* Ladders Estimates

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