Principal Medical Writer – Clinical Focus

This is a fully remote position, open to applicants in Germany, +1 more country.

📋 Description

• Proactively plan and create regulatory documents and medical communications that support all aspects of product development.

• Organize, analyze, interpret, and present scientific and statistical data effectively.

• Ensure compliance with ICH guidelines, other regulatory standards, and company documentation protocols.

• Take charge of submission-level sections of intricate clinical documents while adhering to timelines and budget constraints.

• Assume responsibility for clear objectives and guide teams towards unified project goals.

• Utilize expertise across various therapy areas to achieve business successes.

• Share medical writing knowledge to enhance organizational capabilities.

• Operate under the guidance of Medical Writing leadership.

• Collaborate with cross-functional teams, both internal and external, for document production.

⛳️ Requirements

• A Bachelor’s degree is required; a background in a science-related field is preferred.

• At least 7 years of medical writing experience within a contract research organization or a pharmaceutical/biotechnology research environment.

• Additional professional and/or educational experiences may be considered toward meeting this requirement on a case-by-case basis.

• Capability to lead submission-level sections, including Clinical Study Reports, Protocols, Investigator Brochures, Integrated Summary of Safety, and Integrated Summary of Effectiveness.

• Extensive experience and technical proficiency across multiple therapy areas.

• Advanced understanding of ICH and related regulatory standards.

• Exceptional written English skills with a strong focus on detail.

• Excellent interpersonal and communication abilities.

• Proficiency in Microsoft Office Suite, particularly advanced skills in Microsoft Word.

• Driving/travel requirements: 0–10% (both national and international).

• Ability to occasionally lift or move up to 25 lbs.

• Weekly work hours are to be established in compliance with local regulations.

🏝️ Benefits

• Remote working options available.

• Flexible time off policy.

• Paid holidays.

• Medical insurance coverage.

• Tuition reimbursement program.

• Retirement savings plans.

• A flexible and inclusive workplace culture.