Senior Medical Writer

Job Title: Senior Medical Writer

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Experience Required:

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Role Summary:

Senior Medical Writer

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.