Regulatory Technical Writer Specialist

3 weeks ago

New York, New York, United States Lifelancer Full time
Job Title

Regulatory Technical Writer Specialist - Global Regulatory Affairs

About the Role

We are seeking a highly skilled Regulatory Technical Writer to join our team in the Global Regulatory Affairs department. As a Regulatory Technical Writer, you will play a crucial role in supporting regulatory document writing to develop the global evidence base for company development programs.

Responsibilities
  • Prepare, write, edit and review high-quality regulatory documents founded in regulation and supported by science for submission to regulatory agencies and health authorities.
  • Provide support for the preparation and submission of critical regulatory documents and responses to health authority information requests using available reference materials, scientific literature, and content provided by the Global Regulatory Affairs team members functional area contributors.
  • Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members.
  • Work closely with team members on the strategic content of target documents.
  • Collaborate with project teams and functional area contributors to advance global regulatory programs and product development projects.
Requirements
  • BA, BS or equivalent experience in a related field.
  • 4-8 years of experience.
  • Excellent scientific writing skills.
  • Proven experience performing literature reviews, analyzing data and communicating outputs.
  • Experience working within a medical device or pharmaceutical organization in a Research Development, Scientific and Medical Affairs, Clinical or Regulatory role.
  • Experience writing scientific documents for regulatory or journal submissions.
  • Demonstrated ability to build positive constructive relationships with cross-functional team members.
  • Extensive knowledge of MDD, MDR and MEDDEV requirements.
What We Offer

We offer a competitive salary range of $93,500 - $133,660 per annum. Additionally, we provide a comprehensive benefits package including medical, dental and vision coverage, paid time off plan, health savings account (HSA), 401(k) savings plan, access to wages before pay day with myFlexPay, flexible spending accounts (FSAs), short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programs.

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