Scientific and Medical Writer

Job Locations US-MA-Lexington
Job ID


Agenus is seeking an experienced scientific and medical writer and expert in medical communication with hands on experience in drug development for at least 7 years in the international pharmaceutical industry, academia or consultancy. Management experience of cross-functional team is a prerequisite. The position is highly visible to internal and external stakeholders and requires political savvy and agility in building consensus and formulating medical, clinical and safety messages to ensure high quality documentation that meets regulatory standards.This is an outstanding opportunity for a highly experienced scientific and medical writer versed in drug development, medical communication and regulatory documentation in the biotech arena to join motivated and growing team in a highly innovative immune-oncology company.


  • Writing, updating and coordinating protocols, investigator’s brochures, annual reports and related clinical and medical documentations, INDs, briefing documents for health authority meetings, TPP, CCDS, prescribing information, and other regulatory documents in conjunction with the project team according to Agenus document standards and SOPs
    • Managing and writing components of CSRs, CTDs, for program completion and BLA and MAA submission (in collaboration with regulatory, clinical, non-clinical, safety, CMC, commercial) and ensure readiness for submission to health authorities
  • Provides mentoring support to less experienced colleagues and new Company staff members and contractors involved in regulatory documentations.
  • Drive document writing and review processes, develop and maintains timelines for document generation, revision, and completion, with collaboration with other project 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 business unit and across the organization
  • Contribute to the development of electronic document systems and tools and regulatory filing documentation systems.
  • Provide project team(s) with guidance and problem resolution related to document generation


 The successful candidate should possess the following qualifications, experience and attributes…

  • University qualification in a relevant life science discipline; preferably with a higher academic qualification (PhD, PharmD)
  • Demonstrated experience of at least 7 years in clinical development, medical communication, regulatory documentation with strong interpersonal skills, time management, project management, and technical writing skills
  • At least 2 years’ experience in medical writing in oncology
  • Experience preparing clinical and safety regulatory documents is crucial.
  • Prior NDA/BLA/MAA submission experience, including eCTD
  • Prior exposure to FDA or national health agency, 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.
  • In depth understanding of all regulatory guidance’s, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA);
  • Experience in electronic document management and electronic regulatory submissions, tools and standards
  • Demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas in cross functional team settings and to senior management.
Core Competencies
  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Ability to articulate, influence and lead CTD compilation with cross-functional team toward successful outcome
  • Ability to build consensus and interact effectively with internal and external customers
  • Ability to work effectively across functions in drug development and commercial organizations
  • Team player with good interpersonal skills
  • Strong oral and written communication skills
  • Good presentation, organization and planning skills
  • Fluency in English, written and spoken - knowledge of other languages valuable


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