Job Title: Associate Manager - Regulatory Solutions
Date Posted: 20 February 2025
Location: Bangalore, KA, India
About Indegene:
Indegene is a technology-driven healthcare solutions provider, committed to enabling healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for bold, industrious, and nimble talent. At Indegene, you gain a unique career experience that celebrates entrepreneurship, innovation, collaboration, and empathy. Join us at the intersection of healthcare and technology for an exciting career journey.
To explore opportunities with us, visit careers.indegene.com.
Role Purpose:
The Associate Manager - Regulatory Solutions is responsible for handling complex medical writing projects, providing review support for regulatory writing deliverables, and training junior writers. This role plays a key part in supporting clinical regulatory writing, including global filings (CTD Module 2 and Module 5).
Education & Experience Requirements:
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
Experience: 10 to 12 years of experience in writing clinical and regulatory documents supporting global filings (CTD Module 2 and Module 5).
Key Responsibilities:
Medical Writing & Content Development:
Prepare/review clinical study reports (CSRs), protocols, investigator brochures (IBs), submission documents (Module 2 summaries), and other regulatory documents for investigational drugs in various clinical development stages.
Apply lean authoring principles and structured content management for document development.
Team Leadership & Project Management:
Lead cross-functional teams to draft agreed-upon scientific and medical content addressing data interpretation, product claims, and internal/external questions.
Manage and coordinate work plans for individual and multiple document deliveries, ensuring timelines and roles are clear for efficient document completion.
Ensure adherence to content standards, lean authoring processes, and messaging across team members.
People management experience for over 2 years, with potential to train junior writers and oversee the work of team members.
Process Coordination:
Coordinate document review meetings, consensus building, quality control, and document finalization within tight timelines.
Ensure proper communication and documentation for project milestones, and drive the team towards timely document delivery.
Compliance & Continuous Improvement:
Stay current with regulatory requirements and industry trends, ensuring compliance with company standards and best practices.
Share lessons learned and drive continuous improvement in the medical writing process.
Skills & Qualifications:
Medical Writing Experience:
Expertise in authoring a broad range of clinical documents for regulatory filings, with preference for experience with Module 2 (2.4, 2.5, 2.6, 2.7), Module 5.2, CSRs, protocols, amendments, informed consent forms (ICFs), and Investigator Brochures (IBs).
Project Management & Leadership:
Strong project management skills with the ability to coordinate tasks, roles, responsibilities, and timelines for both individuals and teams.
Proven ability to lead and manage teams effectively, ensuring deadlines are met and quality is maintained.
Communication & Organizational Skills:
Strong written and verbal communication skills, with an ability to facilitate meetings and ensure alignment among team members.
Excellent time management, organizational, and interpersonal skills.
Regulatory Knowledge:
In-depth knowledge of global regulatory guidelines and the ability to interpret data for regulatory documents (e.g., IB, protocols, CSR).
Understanding of clinical development processes from program planning to submission, including clinical trial design.
Technology Proficiency:
Expert-level proficiency in MS Word, with experience in document management systems and working with Word add-ins for document formatting and reference management.
Flexibility to adapt to new tools and technologies, and the ability to train others on their usage.
Responsibilities:
Independently prepare/review clinical documents (e.g., CSRs, protocols, IBs) in accordance with regulatory requirements.
Coordinate document review processes, ensuring that feedback is addressed and that final documents meet all requirements.
Develop and manage work plans for the medical writing team, ensuring efficient document delivery and adherence to timelines.
Facilitate communication within the team and across cross-functional departments.
Ensure adherence to company and sponsor-defined processes and best practices.
Equal Opportunity Employer:
Indegene is proud to be an Equal Employment Employer, fostering a culture of inclusion and diversity. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. Employment decisions are made based on merit, qualifications, and business requirements.
Contact Information:
For further inquiries or to apply, please visit Indegene Careers.
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