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Syndax Pharmaceuticals is looking for a Senior Manager, Medical Writing

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role: 

Syndax is looking for a motivated and experienced senior medical writer as a Senior Manager to be responsible for clinical and nonclinical regulatory documents to support marketing authorization applications including an anticipated NDA/BLA filing, as well as study protocols, Investigator Brochures, Clinical Study Reports, briefing books, Annual Reports and INDs in support of ongoing clinical development, and clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts).

Key Responsibilities:

  • Writes, reviews, and edits the following:
  • Regulatory Documents: clinical and non-clinical modules of NDAs and MAAs, clinical protocols, clinical study reports, investigator’s brochures, annual reports, DSURs, INDs, and other regulatory documents in conjunction with the project team.
  • Drives document writing and review processes, by managing document content and presentation of content, and developing timelines in collaboration with team members.
  • Ensures consistency across documents in a program and supports consistency in company documents, including through the development of document templates.
  • Guides the team in the generation of documents and takes the lead in resolution of document problems.
  • Works cross-functionally to evolve document preparation and document content practices, to improve quality or efficiency.
  • Represents medical writing function as an integrated member of clinical study teams.
  • Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization.
  • Manages outsourced writing projects with contract medical writers as necessary.
  • Supports the development and maintenance of SOPs for the function and writing tools, such as templates and style manuals, and can provide training within the department and across departments.
  • Oversees quality control (QC) of documents/supports other writers by QCing documents.
  • Proactive problem solver, exercising sound judgment and appropriate flexibility within a dynamic environment.
  • Acts as an authoritative resource within specialty area to internal and external resources.
  • Works effectively with colleagues from other departments in team situations.

Desired Experience/Education and Personal Attributes:

  • Bachelor’s degree and 4-6 years of hands-on medical writing, with experience at a senior level for 2+ years. Experience should have been gained directly in pharmaceutical/biotechnology companies and include authoring a wide range of documents (e.g., protocols, IBs, CSRs, briefing books, PIPs, special designation requests, documents contributing to global submissions, such as NDAs and MAAs) from inception through completion.
  • Proven ability to act as lead author on different types of clinical and regulatory documents, including project management.
  • Experience with the oncology therapeutic area.
  • Ability to analyze, summarize and interpret clinical data.
  • Expertise in MS WORD, with the ability to solve technical problems with documents and templates.
  • Knowledge of FDA and ICH guidelines.
  • Excellent written and oral communication skills, including functional literacy.
  • Understanding of the scientific process and clinical research.
  • Familiarity with industry trends for clinical documents and international dossier preparation, including electronic document submissions.
  • Experience working on complex projects, within cross-functional teams.
  • Working knowledge of the eCTD format.

Location: Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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Confirmed 17 hours ago. Posted 28 days ago.

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