Scientific Writing Lead – Indegene – in Hyderabad, Apply Now!
Are you ready to take the next leap in your scientific writing career? Indegene is hiring a Scientific Writing Lead to join its mission-driven, technology-led healthcare team. This role offers a unique opportunity at the intersection of healthcare and innovation, where you’ll lead clinical affairs documentation for medical devices, mentor a talented team, and help shape the future of MedTech. If you’re looking for a fast-paced, global growth environment backed by stability and purpose—this could be your next career move.
Location: Hyderabad, Telangana, India
Role: Scientific Writing Lead
About the Job:
We are looking for a Scientific Writing Lead to join our team. Our ideal candidate is a graduate or postgraduate in Life Sciences or Biomedical Engineering with 5-7 years of total work experience, including at least 4 years in the medical device clinical affairs domain.
Education: Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Bio Medical Engineering
Experience for Scientific Writing:
- 5 to 7 years of total work experience, with at least 4 years in the medical device clinical affairs domain.
- Sound experience in the application of therapeutic and device knowledge for development of clinical evaluation documents
- Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development.
- Strong experience in conducting literature searches, reviews and appraisal of the scientific data
- Proficiency in using DistillerSR for systematic review management and data extraction.
- Clear and effective communication, both verbal and written as Scientific Writing
- Excellent critical and analytical thinking skills
- Review experience in clinical evaluation (CEP/CER/SSCP) and post-market deliverables (PMSR/PSUR/PMCFP/PMCFER), IVDRs (PEP/PER)
- High level of attention to detail and accuracy
- Able to work effectively with cross-functional teams
- Able to manage multiple projects across numerous disciplines.
- Strong communication, presentation and interpersonal skills with high attention to detail and organization as Scientific Writing
- Consistent dedication and strong work-ethic to help meet aggressive timelines or multiple projects when necessary
- People management, with ability to manage a team of 3-5 writers
Skill Set:
- Experience in leading a team
- Experience in creating process flows, SOPs, Templates
- Good understanding of medical devices and an overall understanding of the medical field preferred as Scientific Writing.
- In-depth knowledge of EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF and MDCG; translate the client requirements and apply in drafting of CE documents
- Good knowledge on EU MDR specifics related to Clinical Evaluation, Clinical risks and Benefits, Safety and Performance etc
- Expertise in DistillerSR for automating and managing systematic reviews efficiently
- Strong flair and passion for technical writing
- Strong written and verbal communication/presentation skills
- Being up-to-date with the latest technical/scientific developments and relating them to various projects as Scientific Writing.
- Ability to understand client requirements and KPIs
Equal Opportunity: Indegene is an Equal Employment Employer committed to fostering a culture of Inclusion and Diversity. We do not discriminate based on various characteristics and ensure that all employment decisions are based on business requirements and qualifications.
Keywords: Scientific Writer, Life Sciences, Medical Device, Clinical Affairs, Healthcare, Technology, DistillerSR, Technical Writing
