Senior Medical Writer

About Us

Evestia Clinical is a biotech-focused global CRO delivering authentic expertise and personalised support where clients need it most. Following our recent merger with ICRC‑Weyer, an experienced life science consultancy based in Berlin, we are expanding our German team and looking for passionate colleagues to join us.

Our foundation is built on four core principles: Innovation drives us to seek new solutions, Excellence defines the high standards we keep, Care ensures a supportive culture for patients and people, and Partnership underpins the collaborative way we work. We offer an agile, flexible, and inclusive environment where you are empowered to find creative solutions and make a meaningful impact on clinical development across rare disease, oncology, neurology, immunology and inflammation.

About the Role

We are seeking a Senior Medical Writer to join our Medical Writing and Pharmacovigilance Team and take ownership of clinical, regulatory and safety writing projects. This is a full‑time, hybrid role reporting to the Head of Medical Writing and Pharmacovigilance, with one to two days per week based in our Berlin office.

Key Responsibilities

• Prepare a wide range of documents for global submission across all phases of clinical development and post‑marketing, spanning multiple therapeutic areas.

• Draft and edit documents such as clinical study protocols and reports, clinical overviews and summaries, Investigator’s Brochures, aggregate safety reports and Risk Management Plans.

• Collaborate closely with cross‑functional teams, including pharmacovigilance, regulatory affairs and clinical development, to ensure documents are accurate and submission‑ready.

• Review complex documents for consistency, scientific accuracy and alignment with client standards and regulatory requirements (e.g., ICH, GVP, MDR).

• Manage review cycles and project timelines in coordination with clients and internal stakeholders to meet delivery milestones.

• Act as a subject matter advisor on medical writing and regulatory documentation for clients and internal teams.

• Mentor, train and provide constructive feedback to junior writers to support their development.

What You Will Need to Succeed

• Established experience as a medical writer within a CRO, biotech, pharmaceutical or medical device environment.

• Proven expertise in preparing at least three types of clinical, regulatory or safety documents (for example study‑related, submission‑related or safety‑related documents).

• Strong knowledge of the drug development lifecycle and key regulatory requirements (ICH and GVP); familiarity with medical device guidance (MDR 2017/745, ISO 14155, MDCG) is advantageous.

• Ability to interpret and summarise complex clinical and safety data clearly and precisely.

• Proficiency in literature database searching and referencing software.

• Advanced MS Word skills (Word 365) and a willingness to learn and adopt new tools and processes.

• Strong communication, organisational and stakeholder management skills, with a focus on quality and timelines.

Our Offer

• Hybrid‑remote working with team collaboration days in our Berlin office; fully remote arrangements where appropriate.

• A supportive, diverse and engaged team with flat hierarchies and genuine opportunities for professional growth.

• Permanent contract with a competitive salary and an attractive benefits package.

• Access to professional development programmes, including support for EMWA membership and continued training.

How to Apply

If you are motivated by making a global impact and feel you would thrive in our collaborative environment, we would love to hear from you. We hire for potential and passion—if you do not meet every criterion but believe you are a good fit, please submit your application.

Our Commitment to Inclusion and Diversity

We are proud of our people and the successes we achieve together. We actively seek and welcome individuals with diverse backgrounds, voices, beliefs and perspectives. At ICRC‑Weyer and Evestia Clinical , we celebrate individuality and foster an inclusive culture guided by Innovation, Excellence, Care and Partnership. Our managers are committed to equitable practices across hiring, promotion, training and benefits.

Equal Opportunity & Accessibility

ICRC‑Weyer / Evestia Clinical is an equal opportunity employer. We ensure fair treatment of all applicants and employees, without discrimination based on actual or perceived race, colour, creed, religion, national origin, age, sex, gender identity or expression, sexual orientation, disability, veteran status or any other characteristic protected by applicable law.

We are committed to providing accessibility accommodations to applicants with physical and/or mental disabilities. If you require an accommodation during the application process, please contact our recruitment team at [email protected] .