Senior Medical Writer

Veristat

Denver (CO)

Hybrid

USD 110,000 - 160,000

Full time

6 days ago
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Job summary

Veristat is seeking a Senior Medical Writer to independently plan and prepare regulatory documents and medical communications to support all phases of product development. The role emphasizes organizing, interpreting, and presenting scientific data in line with ICH guidelines and company standards.

You will collaborate with cross-functional teams, contribute to high-quality documentation, and work under Medical Writing management to ensure timely deliverables.

Qualifications

  • Bachelor’s degree required; science-related field preferred.
  • Minimum of 5 years of medical writing experience in a CRO or pharmaceutical/biotech setting; minimum of 3 years of formal medical writing.
  • Advanced knowledge of ICH and related regulatory guidelines.
  • Excellent written English and keen attention to detail.
  • Strong interpersonal and communication skills.
  • Experience with Microsoft Word is essential, including advanced proficiency.

Responsibilities

  • Plan and prepare regulatory documents and medical communications across product development.
  • Organize, analyze, interpret, and present scientific and statistical information per ICH guidelines and company standards.
  • Collaborate with cross-functional internal and external document production teams.
  • Work under the direction of Medical Writing management to ensure quality and timeliness.

Skills

Medical writing
ICH guidance
Excellent written English
Interpersonal communication
Microsoft Word proficiency

Education

Bachelor's degree in science-related field

Tools

Microsoft Word

Job description

Job Description:

Senior Medical Writer

The Senior 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 Senior 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 look for
  • Bachelor’s degree required; science-related field preferred.
  • Minimum of 5 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; however, a minimum of 3 years of formal medical writing experience is required.
  • 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.

#LI-SI1

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

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