Senior Medical Writer (Regulatory: IBs, ICFs, CSRs, Synopsis, Protocols, Biostatistics)
Location: Remote (Global)
Job Type: Full-time
Department: Medical Writing – CRO
Company Overview:
Ergomed is a rapidly growing, full-service mid-sized CRO specializing in Oncology and Rare Disease. Established in 1997, we have expanded across Europe, North America, and Asia through strategic growth and acquisitions. Our culture fosters employee visibility, creative input, and genuine career advancement. We prioritize employee well-being, mental health, and work-life balance to deliver high-quality client service and positively impact patients’ lives.
Job Description:
The Senior Medical Writer will be responsible for producing high-quality, regulatory-compliant technical documents to support clinical study activities (Phase I–IV, including PASS). You will collaborate with sponsors, project managers, clinical teams, medical monitors, biostatistics experts, and other stakeholders to ensure accuracy, clarity, and timeliness of deliverables.
Key Responsibilities:
Develop, write, edit, review, and maintain technical documents in compliance with industry best practices, regulatory standards, and internal SOPs.
Prepare and manage a range of documents including:
Synopsis and Protocols
Informed Consent Forms (ICFs)
Investigator’s Brochures (IBs)
Clinical Study Reports (CSRs)
Development Safety Update Reports (DSURs)
Patient narratives
Regulatory submission documents (IMPD/IND/CTA/CTN)
Common Technical Document (CTD) modules
Lay summaries
Collaborate closely with multidisciplinary teams to ensure accurate scientific and clinical content.
Interpret complex data, especially in areas such as Oncology and Neurology, and present findings clearly for regulatory submissions.
Ensure timely delivery and maintain document version control.
Qualifications:
Bachelor’s degree in Life Sciences or related field (Master’s or Doctoral degree preferred).
Minimum 6 years’ experience in clinical research or technical/medical writing.
Proven expertise in technical writing, editing, and reviewing regulatory documents.
Strong understanding of the clinical development process and regulatory submission requirements.
Advanced knowledge in specialized therapeutic areas such as Oncology and Neurology.
Familiarity with global trial submission standards.
Why Join Ergomed:
Equal opportunity employer with a diverse, inclusive, and collaborative work environment.
Global team environment with English as the company language.
Strong focus on training, career development, and personal growth.
Supportive and friendly workplace culture.
Core values: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships.
Estimated Salary Range: USD $85,000 – $110,000 annually (Based on experience and location)
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