Lead-Clinical Affairs

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations 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 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. If this excites you, then apply below. Roles and responsibilities: Responsible for authoring Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Post-Market Surveillance Reports (PMSR), Periodic Safety Update Reports (PSUR), Annual Summary Reports (ASR), Post-Market Clinical Follow-up Plans and Evaluation Reports(PMCFP/PMCFER) Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature Develop literature search and data extraction strategy for search, screening, and summarization of articles, and develop in-depth knowledge and understanding of current scientific literature Participate in and/or perform comprehensive literature searches to support identified product lines and related clinical studies Stay informed about applicable clinical landscapes and trends Review literature search results and interpret and summarize risks, alternate therapies and device specific benefits; collect and summarize primary data to support risk assessment Critically appraise scientific literature and write clinical summaries for products literature to elucidate the clinical problem and current treatment techniques Evaluate data for similar competitor devices Perform data fact check of the documents authored Collaborate with the project/program stakeholders for product information to develop quality content for CERs, within the required timelines Manage assigned client account and ensure successful on time delivery of all deliverables as listed in the SoW Responsible for end to end technical execution of the project Work with PMO to ensure resources with the right skill set are assigned to the project Work with PMO for resource allocation and end-to-end project plan Act as client point of contact for day-to-day communication and project execution Guiding writers on end-to-end execution of the assigned deliverable Day-to-day communication with primary and supporting writer for project execution Review queries for project Kick-off meetings and status update calls Review assets tracker Guiding team members in product understanding, gathering inputs, literature search strategy and systematic literature review, literature screening and data extraction Working as subject matter expert for reviewing, revising and improving the quality of scientific content and content created by primary writers Skills: 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 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 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 Ability to understand client requirements and KPIs Qualifications: Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Bio Medical Engineering with 5 to 7 years experience 4 experience in med 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 Clear and effective communication, both verbal and written 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 withcross-functional teams Able to manage multiple projects across numerousdisciplines. Strong communication, presentation and interpersonal skills with high attention to detail and organization 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 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, 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.

Location: bangalore, IN

Posted Date: 6/17/2025