Regulatory Medical Writer Lead
3 days ago
About the Company
Indegene is a technology-led healthcare solutions provider driven by its purpose to enable healthcare organizations be future ready. With accelerated, global growth opportunities for talent that's bold, industrious, and nimble, Indegene offers a unique career experience that celebrates entrepreneurship, passion, innovation, collaboration, and empathy.
About the Role
The Senior Medical Writer is responsible for developing and reviewing medical writing deliverables that support the clinical regulatory writing portfolio and training junior writers. As a key member of the Medical Writing team, you will work closely with cross-functional teams to draft scientific and medical content addressing data interpretation, product claims, and internal/external questions.
Responsibilities
- Prepare and review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development without guidance from senior members of the writing staff.
- Apply lean authoring principles as part of document development and use structured content management text libraries when applicable.
- Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines.
- Develop and maintain project plans to ensure timely completion of documents.
- Work as an active member of cross-functional teams representing Medical Writing and coordinate document kick-off meetings with writers and cross-functional representatives.
- Ensure adherence to standard content, lean authoring, and messaging across team members and facilitate open communication between members.
- Possible participation in the orientation and coaching of junior team members.
- Conduct literature searches and screening as needed.
- Participate in Medical Writing department initiatives as appropriate.
- Research regulatory requirements to remain current in the regulatory landscape.
- Share lessons learned and best practices.
- Ensure compliance with company training and time reporting.
Qualifications
To be successful in this role, you should possess the following qualifications:
- A MBBS/PhD/MDS/BDS/MPharm/PharmD degree.
- 4 to 8 years' experience in writing Clinical & Regulatory documents for global filings (CTD Module 2, 4, and Module 5).
Required Skills
- Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, and Investigator Brochures (IBs).
- Demonstrated excellence in focused/lean writing and editing following defined processes and templates.
- Lead cross-functional teams to draft agreed-upon scientific/medical content addressing data interpretation, product claims, and internal/external questions.
- Understanding of clinical development process from program planning to submission, including clinical trial design.
- Communication skills commensurate with a professional working environment.
- Effective time management, organizational, and interpersonal skills.
- Candidate should have customer focus, comfortable following directions, templates, and structured processes for delivering documents for review and finalization, and able to work independently while maintaining communication with the Sponsor's MW project manager.
Estimated Salary: $120,000 - $150,000 per year based on location and experience.
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