Job Description
Vacancy for Senior Associate – Scientific Writing at Indegene 2023.
| Organization | Indegene |
| Post Name | Senior Associate – Scientific Writing |
| Job Location | Bangalore |
| Official Website | https://www.indegene.com/ |
Job Title/Position:
Senior Associate – Scientific Writing
Job Overview:
Job vacancy for Life Sciences
Job Location:
Bangalore
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What are the Key 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 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
What are the Educational Qualification(s) for Senior Associate – Scientific Writing?
Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Bio Medical Engineering with 4 to 6 years experience
What is the Experience Required for this Job?
- 4 to 6 years experience
- 3+ experience in med device clinical affairs domain
What are the Preferred Skills required for this Job/Position?
- 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
Related:
- Vacancy for Project SRF at National Institute of Pathology 2023
- Vacancy for Regulatory Professional at Novo Nordisk 2023
- Vacancy for Regulatory Medical Writer at Tata Consultancy Services 2023
- Vacancy for Application Chemist-Intern at Thermo Fisher Scientific Inc 2023
- Vacancy for Medical Writer at WebMD 2023
- Vacancy for Project Assistant at NIRRCH 2023
Detailed notice
https://careers.indegene.com/job/Bangalore-Senior-Associate-Scientific-Writing-KA/19836144/
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