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What You Should Know About This Job
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
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 reportsAct as client point of contact for day-to-day communication for the assigned deliverableDraft queries for Project Kick-off meeting / callDevelop & maintain the assets tracker related to the deliverableReview received assets from client, update tracker and request for additional source documents as requiredAlign with Peer-reviewer and Technical project lead on planned timelines for release of the deliverableAcquire knowledge of therapeutic areas, competitor devices, current clinical / market developments, literature review processesParticipate in and / or perform comprehensive literature searches to support identified product lines and related clinical studiesStay informed about applicable clinical landscapes and trendsReview literature search results and interpret and summarize risks, alternate therapies and device specific benefits; collect and summarize primary data to support risk assessmentCritically appraise scientific literature and write clinical summaries for products literature to elucidate the clinical problem and current treatment techniquesEvaluate data for similar competitor devicesPerform data fact check of the documents authoredEnsure documents comply with the client / regulatory requirementsParticipate in client calls per project requirementsCompliance to quality, confidentiality, and securityAdhere and follow quality systems, processes and policiesComply to training and specificationsEnsure all the open action items in the drafts (if any) are notified to ClientResponsible for collation of medical writer and reviewer CVs and DOIsPerform a self Quality Check before sharing draft for review, update and sign the checklistDraft client calls MoMs and share with client for the assigned deliverableGuide writers in the team for literature search and clinical evaluation plans and reportsPeer review, quality check, and data fact check of drafts received from writersFeedback on quality and formatting observations to writersSkills :
Solid understanding of medical devices and a broad knowledge of the medical fieldFamiliarity with key regulatory frameworks, including EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF, and MDCG guidelinesDemonstrates a strong passion for technical writing and scientific documentationExcellent written, verbal, and presentation skills for clear and effective communicationKeeps abreast of the latest scientific and technical developments and integrates relevant insights into ongoing projectsQualifications :
Graduate or Post Graduate in Life Sciences (Pharm.D / M.Pharm / BDS / MBBS) or Bio Medical Engineering with 4 to 6 years experience3+ experience in med device clinical affairs domainAbility 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 dataClear and effective communication, both verbal and writtenExcellent 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 necessaryEQUAL 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.