Veristat

Principal Medical Writer

Veristat • $110K — $130K *
US-AnywhereRemote in Massachusetts, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree required; science-related field preferred.
  • 7+ years of medical writing experience in CRO/pharma/biotech.
  • Advanced knowledge of ICH and regulatory guidelines.
  • Excellent written English with attention to detail.
  • Strong interpersonal and communication skills.
  • Advanced proficiency in Microsoft Word and familiarity with Office Suite.

Responsibilities

  • Plan and prepare regulatory documents and medical communications.
  • Organize and analyze scientific and statistical data.
  • Interpret and present information according to guidelines.
  • Collaborate with cross-functional teams on document production.
  • Maintain adherence to internal documentation standards.

Benefits

  • Remote working options
  • Flexible time off
  • Paid holidays
  • Medical insurance
  • Tuition reimbursement
  • Retirement plans
Full Job Description
Job Description:

Principal Medical Writer

The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards. The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.

What we offer:
• Benefits vary by location and may include:

o Remote working

o Flexible time off

o Paid holidays

o Medical insurance

o Tuition reimbursement

o Retirement plans

What we look for:
• Bachelor's degree required; science-related field preferred.
• Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
• Advanced knowledge of ICH and related regulatory guidelines.
• Excellent written English and keen attention to detail.
• Strong interpersonal and communication skills.
• Experience with Microsoft Office Suite is essential, including advanced Microsoft Word proficiency.

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

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