Work as Scientific Writing Lead at Indegene

We challenge the status-quo, invent, and re-imagine the healthcare industry using deep medical/scientific understanding, bleeding-edge technology, and bold audacious thinking. At Indegene, our teams do their most profound work, think and imagine without limits, and transform the once traditional industry into a modern intelligent enterprise.

Post : Scientific Writing Lead

Job Description
• 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

Candidate Profile
• 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

• 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 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
• People management, with ability to manage a team of 3-5 writers

Additional Information
Experience : 4+ experience
Qualification : Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS)
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th November, 2023