Senior Medical Writer

2 weeks ago

Davangere, India MS CLINICAL RESEARCH Full time

Job Title: Senior Medical Writer Location: MS Clinical Research (MSCR), Department: Medical & Scientific Affairs Reporting To: Director Experience Required: Minimum 10 years in medical/scientific writing Engagement Type: Consultant – Part-time/Project-based/Remote Role Summary: MSCR is seeking a highly experienced Senior Medical Writer to oversee the medical writing function and mentor a growing team of in-house writers. This strategic role will involve managing complex writing projects, reviewing and enhancing document quality, and providing expert guidance to ensure scientific accuracy, regulatory compliance, and writing excellence across all deliverables. Key Responsibilities: - 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. Required Qualifications: - PhD/MD/MPharm/MSc in Life Sciences, Medicine, or Pharmacy. - Minimum 6 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. Preferred 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. Benefits: - Competitive salary and compensation package. - Flexible working hours and remote work options. - Opportunity to work with a dynamic and collaborative team. - Professional development and growth opportunities.

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