Principal Medical Writer

Company: WashingtonLifeScience.com - Jobboard
Location: Bothell
Posted on: February 22, 2021

Job Description:

DescriptionDescription

Summary:

The Principal Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies and may also lead other internal and contract medical writers and collaborators on authoring teams for submission work. The principal medical writer also supports other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.

Principal Responsibilities:

Includes but not limited to

• Prepares Investigational New Drug (IND) applications, amendments, annual reports, New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA), and other documents to support global product development
• Leads the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings in collaboration with clinical study teams
• Leads the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals including direct collaboration with internal and external authors
• Contributes to strategic publication planning and implementation of publication plans, including working with author groups to develop and author manuscripts, abstracts, and presentations for scientific congresses
• Lead the activities of multiple contributors and the document portfolio required for a submission (NDA or early development [IND])
• Provides project teams with expertise and strategic guidance on analysis and presentation of
  clinical and safety data and on benefit-risk assessment in documents
• Organizes, conducts, and leads cross-functional document development meetings
• Develops the strategy for document preparation and manages the overall document development process including timelines, document reviews, and approvals in adherence with company standard operating procedures and regulatory guidance, including the escalation of issues when required
• Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs demonstrating advanced problem solving ability
• Routinely engages clinical research and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiences
• Represents medical writing on multiple study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments
• Lead and/or participate in development of medical writing processes and infrastructure development
• Contributes to clinical trial registry postings and results disclosures on US and EU platforms
• Lead the activity of, or serve as internal contact for contract medical writers and other providers
• Review work of other writers for accuracy, quality, focus, and adherence to format and stylistic requirements
• Serve as mentor for medical writers and senior medical writers
• Develops and implements templates, style standards, and standard operating procedures to ensure consistent and high quality deliverables
  
  Qualifications:
  
  • Minimum of 8 (MS/PhD) to 12 (BA/BS) years of experience in the biopharmaceutical industry with 5+ years (MS/PhD) to 10 years (BA/BS) direct medical writing experience; post-doctoral research may be considered in lieu of 1-2 years industry experience for doctoral level candidates
  • Expertise in preparing clinical regulatory documents and scientific publications is crucial
  • Adept at engaging with senior management and executives
  • Prior NDA/BLA/MAA submission experience, including eCTD, required
  • Excellent written and verbal communication skills
  • Expert ability to interpret and present statistical and clinical data to varied audiences
  • Expert knowledge in therapeutic area
  • Ability to influence and reach compromises cross functionally to produce a quality document
  • Expert understanding of other cross-functional departments/disciplines and how they contribute to the drug development process
  • Expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred
  • Expert knowledge of FDA regulations, ICH guidelines, Good Clinical Practices and the drug development process
  • Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment
  • Flexible with the ability to learn new medical/clinical therapeutic areas and/or indications quickly
  • Familiarity with clinical trial transparency requirements, including ClinicalTrials.gov and EudraCT standards, preferred
  • Experience with effectively managing vendors and contract writers to meet timelines/project.
  • Background in oncology drug development is a plus
    
    Education:
    
    • Minimum of a Bachelor's degree in life sciences field with pharmaceutical industry experience in safety, regulatory, or clinical areas is required. Transferrable skills in other clinical settings may be considered. Masters or doctorate degree qualification in life sciences preferred
      
      As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com .
      
      Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
      
      Job Information
      • Job ID: 55383538
      • Location:
        Bothell, Washington, United States
      • Position Title: Senior/Principal Medical Writer Seagen is a global biotechnology company dedicated to developing revolutionary therapies with real impact.Our visionImproving the lives of people with cancer through innovative targeted therapiesOur missionTo discover, develop, and commercialize transformative cancer medicines to make a meaningful difference in people's lives Manager External Manufacturing Operations Senior Associate or Scientist, Protein Reagent... Cepheid Bothell, WA, United States Manager External Manufacturing Operations

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