Job Title: Senior Associate - Scientific Writing
Location: Bangalore, Karnataka, India (Office-based/Hybrid)
Date Posted: May 9, 2025
Company Overview:
We are a technology-led healthcare solutions provider dedicated to enabling healthcare organizations to be future-ready. At Indegene, we foster a culture that celebrates entrepreneurship, innovation, collaboration, and empathy, offering accelerated global growth opportunities. Join us to grow your career at the exciting intersection of healthcare and technology.
Learn more at www.careers.indegene.com
Role Purpose:
Develop and review content for regulatory documents ensuring quality, compliance, and adherence to global regulatory standards.
Author and review clinical and non-clinical documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), and Lay Summaries under Module 2, 4, and 5 of eCTD.
Understand clinical trial and product life cycle stages and regulatory dossier formats (ACTD/CTD/NeeS/paper).
Key Requirements:
Strong medical, pharma, or scientific knowledge applicable to regulatory content development.
Experience in authoring and reviewing clinical and non-clinical documents within regulatory dossiers.
Good understanding of clinical trial processes and product life cycle.
Excellent written and oral communication skills.
Proficiency in MS Office (Excel and PowerPoint).
Principal Responsibilities & Accountabilities:
1. Content Development & Quality:
Independently draft, update, and review regulatory content with accuracy and timeliness.
Conduct literature searches and screen articles to gather relevant information.
Perform quality checks for data consistency and regulatory compliance.
Extract and synthesize information from authoritative sources while ensuring referencing and plagiarism rules are followed.
Apply best practices in communication, documentation, grammar, and technical writing standards.
Identify challenges in content development and suggest improvements.
Collaborate with internal stakeholders and participate in project and client meetings.
2. Team Content Review:
Review content prepared by junior team members, validating data authenticity and quality.
Guide and mentor juniors on client requirements, quality standards, and document development.
Assist in developing content outlines relevant to different target audiences.
3. Process Adherence & Compliance:
Adhere to organizational and client policies on quality, information security, and data privacy.
Ensure confidentiality and compliance with copyright and company norms.
Follow security standards such as ISMS, ISO, CMMI, and client guidelines.
4. Self-Development:
Support creation of technical training for team members.
Complete client-specific training as required.
Stay updated on current trends and build expertise in assigned deliverables.
Acquire basic team management skills.
Contribute to continuous improvement initiatives.
Education:
MBBS / PhD / MDS / BDS / MPharm / PharmD / BPharm / MSc or equivalent.
Experience:
4 to 6 years of experience in regulatory writing or reviewing.
Equal Opportunity:
Indegene is an Equal Employment Opportunity employer committed to inclusion and diversity. Employment decisions are made without regard to race, religion, sex, color, age, national origin, sexual orientation, disability, or other protected statuses.
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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