Senior Associate - Scientific Writing at Indegene, Bangalore (Hybrid)
Job Summary
Indegene, a leading healthcare solutions provider at the intersection of technology and healthcare, is hiring a Senior Associate - Scientific Writing in Bangalore. This role demands strong regulatory writing skills with 4 to 6 years of experience in authoring and reviewing clinical and non-clinical regulatory documents under CTD/ACTD formats. If you are looking to advance your career in a fast-paced, global healthcare environment, this opportunity is for you.
Key Responsibilities
Develop, review, and ensure quality of regulatory documents like Protocols, CSRs, IBs, ICFs, and Lay Summaries.
Conduct literature searches and review scientific articles to extract relevant information.
Adhere to global regulatory dossier formats (eCTD, ACTD, NeeS).
Perform quality checks on data accuracy and document consistency.
Mentor and guide junior team members in content development and review.
Ensure adherence to company and client-specific quality and compliance guidelines.
Participate in client and internal meetings to ensure smooth project execution.
Contribute to training, continuous learning, and process improvement initiatives.
Required Skills & Qualifications
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc.
Experience: 4 to 6 years of regulatory writing and review experience.
Strong knowledge of clinical trial processes and product lifecycle.
Expertise in Module 2, 4, and 5 of eCTD, and ACTD formats.
Proficiency in MS Office (Excel, PowerPoint).
Excellent written and verbal communication skills.
Ability to guide and mentor junior writers.
Familiarity with quality standards, data privacy, and security norms (ISMS, ISO, CMMI).
Perks & Benefits
Opportunity to work in a rapidly growing global healthcare tech organization.
Exposure to international regulatory standards and guidelines.
Hybrid work model for better work-life balance.
Fast-track career growth with leadership and mentorship opportunities.
Inclusive, diverse, and collaborative workplace environment.
Company Description
Indegene is a technology-led global healthcare solutions company specializing in regulatory writing, scientific content development, and technology-driven healthcare services. It offers accelerated career growth for ambitious professionals at the convergence of healthcare and technology.
Work Mode
Hybrid (Bangalore Office)
Call-to-Action
Ready to take the next step in your scientific writing career? Apply now and become part of Indegene's dynamic and innovative healthcare team.
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