Full-Time Senior Medical Writer
Ergomed is hiring a remote Full-Time Senior Medical Writer. The career level for this job opening is Senior Manager and is accepting Pune, India based applicants remotely. Read complete job description before applying.
Ergomed
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Senior Medical Writer is responsible for the content, quality, and timely delivery of technical documents supporting clinical study activities (Phase I to Phase IV – PASS). This role collaborates with the sponsor, project manager, clinical team, medical monitors, biostatisticians, and others to create content.
Responsibilities include creation, development, review, maintenance, and oversight of all relevant technical documents adhering to industry best practices, regulatory standards, and internal guidelines (SOPs).
Technical documents include Synopsis, Protocols, Informed Consent Forms (ICFs), Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), narratives, Investigational Medicinal Product Documents (IMPD/IND/CTA/CTN), Common Technical Documents (CTD) modules, and Lay summaries.
Qualifications require a Bachelor's degree in life sciences or related field, and a Master's or Doctoral degree is preferred. Minimum 6 years of related experience in clinical research or technical writing, or equivalent. Expertise in technical writing, editing, and review, strong knowledge of clinical development, regulations and relevant technical documents/standards, and understanding of complex topics (Oncology, Neurology) and Trial Submission standards are essential.