Job Title: Associate – Scientific Writing
Company: Indegene
Location: Bangalore, KA, India
Date Posted: 20 Sept 2025
Company Overview
Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. The company emphasizes global career growth, entrepreneurship, and mentorship, operating at the intersection of healthcare and technology.
Role Overview
The Associate – Scientific Writing will join the Safety team, focusing on authoring, reviewing, and performing quality control (QC) of aggregate safety reports and regulatory documents. This role is responsible for maintaining quality, timeliness, and compliance with internal and client SOPs and global regulations.
Key Responsibilities
Manage the entire life cycle of documents, ensuring quality, compliance, and timely delivery.
Author and review complex regulatory safety documents, including:
PBRERs (Periodic Benefit-Risk Evaluation Reports)
DSURs (Development Safety Update Reports)
SUSARs (Suspected Unexpected Serious Adverse Reactions)
PADERs/PAERs (Periodic Adverse Event Reports)
ACOs (Aggregate Clinical Overviews)
RMPs (Risk Management Plans)
Ad-hoc regulatory and safety reports
Liaise with subject-matter stakeholders, resolve review comments, and ensure documents are submission-ready.
Review and format documents per client-specific style guides using Adobe Acrobat and ISI Toolbox, including:
TOC, abbreviations, tables and figures, endnotes, cross-referencing, pagination, and hyperlinks.
Ensure documents adhere to global standards, including FDA, ICH, and GCP guidelines.
Participate in relevant training programs and continuously update skills.
Collaborate with clinical and regulatory experts, external contacts, and clients to ensure scientific accuracy and clarity.
Maintain compliance with quality, confidentiality, and security policies.
Required Qualifications & Skills
Education: Medical/M.Pharm/Pharm.D/Life Sciences degree.
Experience: Minimum 2 years in medical writing or equivalent life sciences experience, including end-to-end authoring of periodic aggregate reports.
Knowledge of regulatory documentation, drug development processes, and global guidelines.
Proficient in document management systems and Microsoft applications (Excel, Outlook).
Excellent written and verbal communication skills.
Strong organizational, time management, and data interpretation skills.
Analytical abilities including verbal reasoning, attention to detail, and critical thinking.
Preferred / Nice-to-Have Skills
Strong interpersonal skills and adaptability to varying environments.
Mentoring skills for junior team members.
Equal Opportunity Statement
Indegene is committed to inclusion and diversity and does not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other protected characteristic. All employment decisions are based on business requirements, merit, and qualifications.
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