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 : Senior Associate - Scientific Writing
Job Description
• 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 productsliterature 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
Candidate Profile
• 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
• Understanding of medical devices or an overall understanding of the medical field
• Understanding of EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF and MDCG
• Strong flair and passion for technical writing
• Strong written and verbal communication/presentation skills
• Bzing up-to-date with the latest technical/scientific developments and relating them to various projects
Additional Information
Experience : 3+ 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 : 30th November, 2023
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