Looking for someone with 5-8 yrs experience who has a full grasp of the CER process, experience with each section, can speak effectively towards clinical, can create literature searches, understanding of MDR and guidance’s. Ideally has written around 10+ CER’s. Position is remote.

Responsibilities:

  • As a lead writer, plans and manages the documentation process, project timelines (in collaboration with Project Management), and resource requirements on large medical writing projects.
  • Writes, edits, reviews, and formats documents that conform to domestic and/or international regulatory submissions (IDEs, PMAs, 510(k), Clinical Evaluation
  • Reports, Technical Files, Design Dossiers, Instructions for Use, Labeling, SSCP, PSUR, etc.) and internal document standards, while meeting project timelines.
  • Coordinates content development with multi-discipline subject matter experts, both internal and external to the company
  • Provides medical writing, editorial and peer-review support for publications, abstracts, posters, white papers and other promotional material.
  • Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly in the document QC process.
  • Attends meetings about document(s) in development and provides management, team and reviewers with document status reports as needed.
  • Supports communication strategy development.
  • Collaborates with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives.

Education:

  • Leadership
  • Strong written and verbal communication skills
  • Analytic skills
  • Collaboration skills
  • Product management skills
  • QA process skills
  • Computer knowledge and skills

Education and Experience:

  • Bachelor’s degree or equivalent experience in life sciences or a related field and 6+ years of medical writing experience in the medical device industry, or;
  • Masters or Doctorate (PhD) degree and 2+ years of relevant experience
  • Advanced degree in Writing/English or completion of a technical writing program in addition to 4-year college degree, is a plus.