Title: Associate - Scientific Writing

Date: 20 Sept 2025

Location:

Bangalore, KA, IN

Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

We seek an ambitious and energetic Medical Writer for authoring of aggregate safety reports to join our Safety team! The successful candidate will be responsible for authoring/performing QC/review of safety documents.
Responsibilities:
• Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.
• Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, reference linking, ensure documents are submission-ready before facilitating approval and handover of the document.
• Review formatting per the client -specific style guide and format PDF documents in Adobe Acrobat and ISI Toolbox which includes review of TOC, list of abbreviations, formatting of tables and figures for consistency in font, alignment, foot note references, portrait and landscape adjustments, etc; endnotes, cross referencing, pagination, bookmarking and hyper-linking.
• Ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines and are in accordance with electronic publishing standards.
• Responsible to participate in assigned training programmes relevant to the job.
• Work and interact extensively with clinical and regulatory experts, as well as external contacts to ensure high quality with regard to scientific content, organization, clarity, accuracy, format and adherence to regulatory and internal guidelines, styles and processes.
• Interface with clients on a regular basis to meet their expectations.
• Orientation Compliance to quality, confidentiality and security.
• Adhere and follow quality systems, processes and policies.
• Comply to training and specifications.
Qualifications:
• Medical/M.Pharm/Pharm D/life sciences degree.
If you are a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.
Your impact:
About you:
• Minimum 2 years’ experience in medical writing or equivalent experience in life sciences domain with experience in end to end authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports
Must have:
• Knowledge of regulatory documentation, drug development process and global regulations and guidelines.
• Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).
• Excellent written and verbal communication skills.
• Excellent organizational and time management skills.
• Excellent data interpretation and presentation skills.
• Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability.
Nice to have:
• Strong interpersonal skills and the ability to be flexible in varying environments
• Good mentoring skills.

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.