Job
Description
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, clinical evaluation plans, post-market surveillance reports, and periodic safety update reports Act as client point of contact for day-to-day communication for the assigned deliverable Draft queries for Project Kick-off meeting/call Develop & maintain the assets tracker related to the deliverable Review received assets from client, update tracker and request for additional source documents as required Align with Peer-reviewer and Technical project lead on planned timelines for release of the deliverable Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes 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 Ensure documents comply with the client/regulatory requirements Participate in client calls per project requirements Compliance to quality, confidentiality, and security Adhere and follow quality systems, processes and policies Comply to training and specifications Ensure all the open action items in the drafts (if any) are notified to Client Responsible for collation of medical writer and reviewer CVs and DOIs Perform a self Quality Check before sharing draft for review, update and sign the checklist Draft client calls MoMs and share with client for the assigned deliverable Guide writers in the team for literature search and clinical evaluation plans and reports Peer review, quality check, and data fact check of drafts received from writers Feedback on quality and formatting observations to writers Skills: Solid understanding of medical devices and a broad knowledge of the medical field Familiarity with key regulatory frameworks, including EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF, and MDCG guidelines Demonstrates a strong passion for technical writing and scientific documentation Excellent written, verbal, and presentation skills for clear and effective communication Keeps abreast of the latest scientific and technical developments and integrates relevant insights into ongoing projects Qualifications: Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Bio Medical Engineering with 4 to 6 years experience 3+ experience in med device clinical affairs domain 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. 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. Consistent dedication and strong work-ethic to help meet aggressive timelines or multiple projects when necessary 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. Show more Show less
