Job Title: Senior Associate - Scientific Writing
Date Posted: 22 February 2025
Location: Bangalore, KA, India
About Indegene:
Indegene is a technology-driven healthcare solutions provider that enables healthcare organizations to be future-ready. We offer dynamic, global growth opportunities for ambitious, innovative, and agile talent. With a career at Indegene, you’ll be at the intersection of healthcare and technology, gaining a unique experience that celebrates entrepreneurship, innovation, collaboration, and empathy.
To explore exciting opportunities with us, visit careers.indegene.com.
Role Purpose:
The Senior Associate - Scientific Writing will take the lead in developing and reviewing medical writing deliverables that support clinical regulatory writing portfolios. This includes training junior writers and ensuring that the writing adheres to regulatory requirements, including those for global filings (CTD Module 2 and Module 5).
Education & Experience Requirements:
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
Experience: 4 to 6 years of experience in writing clinical and regulatory documents supporting global filings (CTD Module 2 and Module 5).
Key Responsibilities:
Medical Writing & Content Development:
Independently prepare/review clinical study reports (CSRs), protocols, investigator brochures (IBs), and other regulatory documents for investigational drugs at various stages of clinical development.
Apply lean authoring principles and structured content management text libraries to the writing process.
Project Management & Coordination:
Develop and maintain project plans, ensuring that tasks, timelines, and roles are clear for efficient document delivery.
Coordinate review meetings, quality control, and document finalization under tight timelines.
Ensure adherence to standard content, lean authoring practices, and messaging across team members.
Facilitate communication among team members and external contributors to ensure smooth progress of projects.
Team Leadership & Training:
Lead cross-functional teams in drafting scientific/medical content that addresses data interpretation, product claims, and internal/external questions.
Mentor and potentially train junior writers to build strong writing capabilities across the team.
Ensure that all team members are familiar with templates, guidelines, and tools, and are capable of adhering to structured processes.
Regulatory Compliance & Continuous Improvement:
Stay up-to-date with regulatory requirements, ensuring that documents meet the highest standards of quality and compliance.
Share lessons learned and best practices within the department and across teams.
Skills & Qualifications:
Medical Writing Experience:
Experience authoring a variety of clinical document types supporting regulatory filings, with a preference for experience with Module 2 (2.3, 2.4, 2.5, 2.7), Module 5.2, CSRs, protocols, Informed Consent Forms (ICFs), amendments, and Investigator Brochures (IBs).
Project Management & Leadership:
Ability to manage tasks, roles, and timelines efficiently, ensuring that projects are completed within deadlines.
Experience leading cross-functional teams and managing workflows effectively.
Communication & Organizational Skills:
Strong written and verbal communication skills, with the ability to collaborate with different teams and stakeholders.
Excellent organizational, time management, and interpersonal skills.
Regulatory Knowledge:
In-depth understanding of regulatory guidelines/requirements, including those from the European Union and the United States.
Strong ability to interpret clinical data and apply scientific knowledge to create regulatory documents.
Technology Proficiency:
Expertise in MS Word, with knowledge of Word functionality, styles, and references.
Experience working with document management systems and managing workflows, e-approval/signatures.
Flexibility to adapt to new tools and technologies, and the ability to train other writers on their use.
Responsibilities:
Independently prepare and review regulatory documents (e.g., CSRs, protocols, IBs) with minimal guidance.
Apply lean authoring principles and structured content management text libraries during the writing process.
Coordinate and lead document review, consensus meetings, and finalization under aggressive timelines.
Develop and maintain detailed project plans, ensuring tasks are completed on time.
Participate actively in cross-functional teams, representing Medical Writing.
Organize document kick-off meetings with writers and cross-functional representatives.
Monitor adherence to process standards and ensure effective communication within teams.
Assist in the orientation and coaching of junior team members.
Conduct literature searches as needed and contribute to departmental initiatives.
Research regulatory requirements and maintain compliance with company policies.
Equal Opportunity Employer:
Indegene is proud to be an Equal Employment Employer, committed to 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. All employment decisions are based on the candidate's merit, qualifications, and business requirements.
Contact Information:
For further inquiries or to apply, please visit Indegene Careers.
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