Company:  Confidential

Job Title: Director/Associate Director Medical Writing

Job Number: 24746

Location: Floor 3 Waltham, MA 02451

Job Description

Syndax is looking for a motivated and experienced senior medical writer to be responsible for clinical and nonclinical regulatory documents to support marketing authorization applications including an anticipated NDA filing, as well as study protocols, Investigator Brochures, Clinical Study Reports, Annual Reports and INDs in support of ongoing clinical development, and clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts). This position will assume the lead writing responsibility for early and late phase clinical development across multiple oncology programs The position will create and deliver a writing strategy to support product development and filing, write content for key documents in close partnership with senior management and development team members, and will interface closely with, and coordinate, existing contract writers.  

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, IMPDs, and other regulatory documents in conjunction with the project team
  • Publications: Manuscripts, abstracts, poster presentations, oral presentations
  • Drives document writing and review processes
  • Represents medical writing function as an integrated member of clinical study teams
  • Develops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
  • 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
  • Develops and maintains SOPs for the function and writing tools, such as templates and style manuals, and provides training within the department and across departments
  • Quality control (QC) of delivered documents
  • Guidance to project teams and problem resolution related to document generation
  • Takes the initiative to solve problems, 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

Required Skills

  • Bachelor’s degree and 7+ years of medical writing or editing experience at a senior level in the pharmaceutical/biotechnology industry, including contributing to global submissions, such as NDAs and MAAs
  • Proven ability to act as lead author on different types of clinical and regulatory documents, including project management
  • Familiarity 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  

 

 

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