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    • Minimum of 7 years of medical writing experience in a contract research organization or pharmaceutical/biotechnology research setting.
    • View all Veristat jobs - Deutschland jobs - Medical Writer jobs in Deutschland
    • Salary Search: Principal Medical Writer- Clinical Focus salaries in Deutschland
    • Is a technical writer with a programmer's mindset, or a programmer with a record of producing excellent documentation.
    • Holds a BSc/BA degree or equivalent.
    • Applicants with prior relevant experience in a medical publications/medical communications agency preferred.
    • Health and wellbeing programmes including medical,…
    • Measure and report on content performance; optimize based on results.
    • The successful candidate is an exceptional writer and content strategist that can break…
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    • Engagement Type: Business-to-Business (B2B) / Independent Contractor.
    • This engagement focuses on high-level advisory and specialized analysis.
    • This position is office based, working Monday – Friday 08:00am – 16:30pm offering a salary of up to £45,000 which will be pending relevant, previous experience.
    • This is an office-based position with some in-office days and some work-from-home days.
    • This role is based in our Loughborough, United Kingdom office.
    • This is an office-based position with some in-office days and some work-from-home days.
    • This role is based in our Loughborough, United Kingdom office.
    • Pricing and reimbursement: Collaborate to secure pricing, reimbursement, and formulary inclusion for new and existing products, leveraging health economic…
    • The role can be home or office based in various European locations.
    • Develop regulatory strategy for medical devices part of combination products.
    • In this role, you’ll be responsible for setting priorities for your work, deciding where to allocate your time based on an assessment of stakeholder and…
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    • A confident writer with experience in healthcare or pharmaceutical advertising, including medical or scientific content.
    • 3+ years' experience writing technical documentation for scientific instruments, laboratory equipment, medical devices or other regulated products.
    • Work closely with the Multiplatform Director (MD) to optimise workflow, allowing writers and editors to contribute to all the brand’s platforms while achieving…
    • Strong emphasis and understanding of a formalized medical device Quality Management System.
    • Direct experience of writing and filing global vigilance reports…
Principal Medical Writer- Clinical Focus
Veristat
·
3.9
Deutschland
•
Remote
Full-time
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Job details

Here’s how the job details align with your profile.

Job type

Full-time

Full job description

Job Description:

Key Purpose:
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:
o Remote working
o Flexible time off
o Paid holidays
o Medical insurance
o Tuition reimbursement
o Retirement plans

Experience & Minimum Requirements:

  • 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.
  • Ability to lead submission-level sections (clinical documents, e.g., Clinical Study Reports, Protocols, Investigator Brochures, Integrated Summary of Safety and Integrated Summary of Effectiveness) taking responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects.
  • Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization.
  • 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.

Additional Requirements:

  • Driving/Travel requirements – 0-10% (national and international)
  • Physical requirements – ability to occasionally lift/move up to 25 lbs
  • Hours/Conditions – minimum weekly work hours set in accordance with local regulations
  • Fair Labor Standards Act Classification – Exempt

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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