Principal Medical Writer – Clinical Research
Company: [Insert Company Name]
Location: Remote, India
Job Type: Full-Time
Category: Medical Writing / Clinical Research
Experience Required: 8+ years
Job Overview
We are seeking a Principal Medical Writer to provide expert-level medical and scientific writing support across clinical development projects. The role involves planning, drafting, and reviewing complex clinical documents, mentoring junior writers, and ensuring compliance with global regulatory standards. This position requires strong therapeutic and scientific expertise and offers the opportunity to contribute to high-impact studies in a remote, global environment.
Key Responsibilities
Medical Writing & Documentation
Research, draft, and edit clinical study reports, protocols, Investigator Brochures (IBs), INDs, and MAAs
Serve as primary author on complex scientific and program-level documents
Review and approve documents prepared by other team members to ensure scientific and regulatory accuracy
Summarize clinical data effectively for regulatory submission and internal use
Leadership & Mentorship
Provide guidance, training, and mentorship to junior medical writers and project managers
Act as subject matter expert in therapeutic areas, regulatory requirements, and document best practices
Lead process improvement initiatives to enhance document quality and efficiency
Project Management Support
Act as backup program manager for assigned projects, including timelines, budgets, forecasts, and contract modifications
Assist in business development activities, such as proposal text review, bid defense meetings, and client presentations
Represent the medical writing function at project launch meetings, review meetings, and team meetings
Education & Experience
Education:
Bachelor’s degree in a scientific discipline (Life Sciences, Pharmacy, Medicine, or related field)
Advanced degree preferred
Experience:
8+ years of experience in medical writing for the pharmaceutical/CRO industry
Proven experience managing complex medical writing projects
Professional certifications (AMWA, EMWA, RAC) are advantageous
Skills & Competencies
Deep understanding of global, regional, and national regulatory guidelines for document preparation
Expertise in therapeutic, preclinical, regulatory, and submission documents
Strong data interpretation, editorial, proofreading, and writing skills
Excellent project management, organizational, and problem-solving skills
Ability to mentor, lead, and motivate junior staff
Advanced interpersonal, communication, presentation, and negotiation skills
High degree of independence, judgment, and decision-making ability
Career Growth & Global Exposure
Exposure to international clinical studies and high-profile therapeutic areas
Opportunity to lead medical writing projects and contribute to regulatory submissions worldwide
Professional development through mentorship, cross-functional collaboration, and leadership opportunities
Enhance skills in AI-enabled writing tools, submission management, and regulatory communications
Why Join
Global Impact: Contribute to life-changing therapies reaching patients worldwide
Leadership Role: Take ownership of complex medical writing projects and mentor junior staff
Professional Development: Access to continuous learning, stretch assignments, and career growth
Innovation: Work with advanced clinical trial documentation tools and global teams
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