Principal Medical Writer- Clinical Focus

Insight Medical Writing, Ltd; Deutschland; Remote; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Remote working

Tuition reimbursement

Job summary

Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents and medical communications across product development stages. You will organize, analyze, and present scientific data in line with ICH and company standards, leading complex submissions with clarity and within timelines.

With 7+ years of medical writing experience in CRO/pharma and strong leadership, you will collaborate across teams and contribute to global regulatory strategies, while

Qualifications

• Bachelor's degree required; science-related field preferred.
• Minimum of 7 years of medical writing experience in CRO or pharmaceutical/biotech setting.
• Ability to lead submission-level sections (CSR, Protocols, Investigator Brochures, ISS/ISE) within timelines and budget.

Responsibilities

• Plan and prepare regulatory documents and medical communications across product development stages.
• Organize, analyze, interpret, and present scientific and statistical information per ICH guidelines and company standards.
• Collaborate with cross-functional teams to produce high-quality, submission-ready documents.

Skills

Medical writing

Leadership

Regulatory submissions

Communication

MS Word

Education

Bachelor's degree in science

Tools

Microsoft Word

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.

Impact Highlights

• 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

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‑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. Veristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives. We are equally proud to recruit, develop and retain the best and the brightest talent across a variety of business functions to make that happen. We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace. Veristat provides equal employment opportunities to all employees and applicants for employment without regard to age, disability, genetics, gender identity or expression, gender reassignment (i.e., transgender status), marriage and civil partnership, pregnancy and maternity, race (including color, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, source of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices. Reasonable Accommodations Veristat is dedicated to providing an accessible and inclusive application experience for all candidates. If you require a reasonable accommodation to complete your application, participate in an assessment, or attend an interview, please contact our Talent Acquisition team at [e-mail] or [phone]. We will work with you to meet your needs, ensuring a fair process. All requests in relation to your application will be treated confidentially. For more information about how we collect and store your personal data during the hiring process, please see our Career Recruitment Notice