• Clinical
  • Lexington, MA
  • This position has been filled

Primary Responsibilities

  • Write, review, and edit clinical and technical documents for organization, clarity, language/grammar, consistency, and scientific standards.
  • Work closely with the clinical team to develop and/or edit clinical documents, including protocols, ROPIs, Investigator Brochures, master Informed Consent Form and other related documents.
  • Work with the regulatory team to author and/or contribute to regulatory submissions, including, but not limited to, briefing documents, safety summaries, IDE/IDE supplements, PMAs.
  • Work with internal teams to develop and/or edit scientific/clinical documents, including medical information materials, manuscripts, abstracts, posters, and slide presentations.
  • Interpret and summarize data from biostatistical summary tables and listings into narrative text (i.e. for safety summaries or clinical study reports) with accuracy, precision, and
  • Organize, conduct, and lead document development meetings and other discussions as necessary, including comment resolution meetings; facilitate efficient review and finalization of documents to be produced.
  • Work collaboratively with study teams on related assignments, representing medical writing.
  • Develop and manage timelines for document development.
  • Maintain familiarity with current industry practices, regulatory requirements, and guidelines that affect medical writing.
  • Identify the need for, and manage, contributions from external medical writing and scientific consultants as necessary.
  • Maintain electronic document/publication management system, supporting the selection and implementation of selected future systems.
  • Bring a “can do” spirit to work and deliver on other responsibilities as assigned.

Education or Certification Requirements

  • Bachelor’s Degree in the Life Sciences, PhD/MS degree is a plus

Professional Work Experience

  • 6+ years of experience as a medical writer preparing clinical/regulatory documents in pharmaceutical, biotech and/or medical device industry
  • Experience using electronic documentation management system preferred

Qualifications and Skills 

  • Successful track record of effective program and project management
  • Technical expertise/computer skills, specifically in Microsoft Office Suite, MS Word templates, Adobe Acrobat, document management systems and concepts of structured content management
  • Knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
  • Strong interpersonal and communication (written and verbal) skills
  • Demonstrated successful track record of identifying issues effectively and proposing solutions while seeking input from internal and external stakeholders as appropriate