Principal Medical Writer

Veristat

Deutschland

Remote

EUR 90,000 - 125,000

Full time

11 days ago
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Benefits offered by this job

Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans

Job summary

Veristat is seeking a Principal Medical Writer in Germany to independently plan and prepare regulatory documents and medical communications across product development, ensuring accuracy and compliance with ICH guidelines.

The role collaborates with cross-functional teams and reports to Medical Writing management, contributing to high-quality submissions and scientific storytelling. Remote options are available within a flexible, inclusive culture at Veristat.

Qualifications

  • Bachelor's degree required; science-related field preferred.
  • Minimum of 7 years of medical writing experience in CRO or pharma/biotech settings.
  • 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, including advanced Word proficiency.

Responsibilities

  • Independently plans and prepares regulatory documents and medical communications.
  • Organizes, analyzes, interprets, and presents scientific and statistical information per ICH guidelines.
  • Collaborates with cross-functional internal and external document production teams.
  • Works under Medical Writing management to ensure high-quality submissions.

Skills

Medical writing
ICH guidelines
Regulatory documentation
Team collaboration
Attention to detail

Education

Bachelor's degree in science-related field

Tools

Microsoft Word
Microsoft Office Suite

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.

Job Description

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.

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

  • 105+ approved therapies for marketing applications prepared by Veristat
  • 480+ oncology projects in the past 5 years
  • 350+ rare disease projects delivered in the past 5 years
  • Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
  • Learn more about our core values here!
What We Offer
  • Benefits vary by location and may include:
  • Remote working
  • Flexible time off
  • Paid holidays
  • Medical insurance
  • Tuition reimbursement
  • 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.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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