PRINCIPAL MEDICAL WRITER

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Medical Writer based in India.

This is a senior-level opportunity for an experienced medical writing professional to lead the development of high-impact regulatory and scientific documents that support global drug development programs. The role combines scientific expertise, strategic leadership, and cross-functional collaboration to deliver high-quality regulatory submissions and evidence-generation projects across multiple therapeutic areas. You will work closely with clinical, statistical, regulatory, and medical teams while serving as a trusted advisor to clients and key stakeholders. In addition to authoring critical documents, you will contribute to process improvements, training initiatives, and operational excellence within the medical writing function. This position offers significant exposure to global regulatory environments and provides the opportunity to influence both scientific communication strategies and team development. It is ideal for a seasoned professional who thrives in a dynamic, client-focused, and quality-driven environment.

Accountabilities

• Independently author, review, and finalize high-quality regulatory documents, including Clinical Study Reports (CSRs), Protocols, Investigator’s Brochures (IBs), Briefing Books, CTD modules, and other submission-related materials for global regulatory agencies.
• Develop scientific and medical communication deliverables such as manuscripts, abstracts, posters, slide decks, and other technical or scientific publications as required.
• Collaborate with statisticians, data analysts, and clinical teams to support real-world evidence generation and other scientific research initiatives.
• Ensure all deliverables meet scientific, regulatory, editorial, and quality standards while adhering to applicable ICH guidelines and industry best practices.
• Perform scientific reviews, quality control assessments, proofreading, and document validation activities to maintain high-quality outputs.
• Lead client interactions, project kick-off meetings, and cross-functional discussions while managing communication across global time zones.
• Serve as a project lead for assigned accounts, ensuring successful delivery, strong client relationships, and overall project satisfaction.
• Drive innovation initiatives, process optimization efforts, and automation opportunities to enhance efficiency and quality within the medical writing function.
• Design and deliver training programs that strengthen technical expertise and support the professional development of team members.
• Support audit readiness activities, contribute to SOP and work-instruction development, and ensure compliance with internal quality systems.
• Participate in business growth initiatives, operational improvements, and strategic departmental activities as needed.
• Provide leadership, coaching, performance management, mentoring, and career development support for medical writing team members.
  
  

Requirements

• PharmD, M.Pharm, PhD, MD, or postgraduate degree in Life Sciences, Medical Sciences, Pharmacy, or a related healthcare discipline.
• 10-11+ years of experience in medical writing, clinical research, or drug development environments.
• Minimum 5 years of hands-on experience authoring regulatory medical writing deliverables for global submissions.
• Strong understanding of clinical development processes, regulatory requirements, and submission standards across major health authorities.
• Experience preparing regulatory documents for agencies such as the FDA, EMA, and other international regulatory bodies.
• Scientific publication writing experience, including manuscripts, abstracts, and posters, is desirable.
• Advanced proficiency in Microsoft Office Suite, particularly Microsoft Word and document management functionalities.
• Excellent written, verbal, presentation, and scientific communication skills.
• Strong organizational, analytical, and problem-solving abilities with exceptional attention to detail.
• Demonstrated ability to manage multiple projects simultaneously while meeting strict deadlines.
• Proven leadership experience with the ability to mentor, train, and develop high-performing teams.
• Strong interpersonal skills and the ability to collaborate effectively with diverse stakeholders at all organizational levels.
• Adaptability, flexibility, and the ability to perform effectively in evolving and fast-paced environments.
• Sound judgment, decision-making capabilities, and a commitment to excellence and continuous improvement.
  
  

Benefits

• Opportunity to work on global clinical development and regulatory submission programs.
• Exposure to diverse therapeutic areas and international regulatory environments.
• Leadership responsibilities with opportunities to mentor and develop medical writing professionals.
• Collaborative, science-driven, and client-focused work environment.
• Involvement in strategic initiatives, innovation programs, and process improvement projects.
• Professional growth opportunities within a globally focused clinical research organization.
• Flexible and dynamic work environment supporting cross-functional collaboration.
• Participation in high-impact scientific communication and evidence-generation initiatives.
• Career advancement opportunities within a growing and specialized medical writing function.
  
  

How Jobgether Works

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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