Agenus

Medical Writer

US-MA-Lexington
Job ID
2017-1266
Category
Clinical

Overview

The Medical Writer will work directly with the Clinical Development and Global Clinical Operations groups on various clinical and regulatory documents ( e.g. study protocols, Drug Safety Update Reports (DSUR), Investigator Brochures, Clinical Study Reports, Annual Reports, INDs, and NDAs) as well as clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts). This individual will assume lead writing responsibility on up to 6 Clinical studies, in various phases of development, potentially leading to an NDA or BLA, including both regulatory and publication documentation (when applicable)

Responsibilities

  • Write clinical protocols, clinical study reports, investigator’s brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with the project team with minimal supervision
  • Write, review, and/or edit publications (manuscripts, abstracts, poster presentations, etc.)
  • Drive document writing and review processes
  • Develop and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
  • Coordinate and manage review cycles, incorporates team comments, and lead discussions on document revision and finalization
  • Must have excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present extremely complex data
  • Assist in the development and maintenance of SOPs and writing tools, such as templates and style manuals
  • Provide training on medical writing templates, SOPs, and processes within the department and across departments
  • Contribute to the development of electronic document systems and tool.
  • Provide quality control (QC) review of various regulatory and medical communications documents
  • Provide project team(s) with guidance and problem resolution related to document generation

Qualifications

  • Bachelor’s degree in a life sciences discipline and a minimum of 3-5 years biopharmaceutical industry experience, or a masters/PhD degree in a life sciences discipline and a minimum of 3 years biopharmaceutical industry experience.
  • Minimum of 2 years Oncology Medical Writing experience.
  • Experience preparing clinical regulatory documents and scientific publications are crucial.
  • Prior NDA/BLA/MAA submission experience, including eCTD, is preferred.
  • Must have a solid understanding of FDA/ICH guidelines and GCPs.
  • Must have strong written and verbal communication skills, and expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred.
  • The candidate must have an in depth understanding of all regulatory guidance’s, standards and requirements pertaining to regulatory medical writing worldwide (eg ICH, FDA, EMEA);
  • The candidate must have experience in electronic document management and electronic regulatory submissions, tools and standards
  • The candidate must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas in cross functional team settings.

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