• Lead and manage medical writing assignments, including protocols, clinical study reports, regulatory documents, manuscripts, abstracts, and presentations
• Mentor and supervise junior and mid-level medical writers, providing developmental feedback, training, and quality review
• Ensure consistency, clarity, and scientific accuracy across all documents
• Review and approve materials related to clinical trial registration (e.g., CTRI entries) and ethics committee submissions
• Guide the team on best practices for literature review, referencing, and scientific integrity using sources like PubMed, NIH Library, and NLM databases
• Provide strategic input on publication planning, conference material development, and stakeholder communications
• Collaborate closely with cross-functional teams including researchers, project managers, and external consultants to align on deliverables
• Maintain up-to-date knowledge of global regulatory writing standards (e.g., ICH-GCP, GPP3, CONSORT)
• Recommend and implement process improvements, templates, and SOPs for documentation
• Provide oversight for version control, formatting, and adherence to SOP MSCR/GEN/03-03
• PhD/MD/MPharm/MSc in Life Sciences, Medicine, or Pharmacy
• Minimum 10 years of medical writing experience, preferably in a CRO or clinical/preclinical research setting
• Demonstrated experience managing or mentoring a team of writers
• Strong command of written English and scientific communication
• Proficiency with referencing tools (e.g., EndNote) and document management systems
• Excellent organizational and project management skills
• Experience in preclinical (in-vitro/in-vivo) and clinical trial documentation
• Exposure to publication strategy and submission to peer-reviewed journals
• Familiarity with tools like CTD structure, CTRI submission portals, and regulatory publishing platforms
• MS Clinical Research (MSCR) is a clinical research organization (CRO) focused on providing comprehensive services in medical writing, regulatory affairs, and pharmacovigilance.
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