Regulatory Writer I Job Vacancy in IQVIA Bengaluru, Karnataka – Latest Jobs in Bengaluru, Karnataka

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Company Name : IQVIA
Location : Bengaluru, Karnataka
Position : Regulatory Writer I

Job Description : Job Overview
Acts as a MedTech Medical Writer on more advanced writing projects, more challenging initiatives or customers. Prepares assigned MedTech documents including clinical/performance evaluations, evaluation reports, post market surveillance plans and reports for either internal customers or external clients. Documents may be related to medical devices, combination products and in-vitro diagnostics (IVD) with content consistent to industry regulations and client specifications.
Builds strong, lasting relationships with internal colleagues and client teams.
Prepares assigned documents in accordance with IQVIA MedTech Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Negotiates timelines and discusses/resolves client comments. Provides written and verbal feedback to clients when appropriate.
Keeps abreast of current medical and/or technical writing/regulatory knowledge, along with developments and advances in medical device/IVD and/or technical writing.
Essential Functions
Preparation of assigned documents including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, communicating directly with the customer.Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.Attend project team meetings with or without other writers. Participate in/lead comments resolution or similar meetings with external customers.May give simple presentation to an existing customer (e.g. on processes at a Kick-off meeting).May develop the content and deliver training to small teams or individuals within IQVIA on the role of Technical Writing, processes, or on a topic he/she has specific expertise in.May provide guidance to more junior colleagues.Read and understand assigned Medical Writing Standard Operating Procedures (SOPs).Complete project finance activities, including monitoring and forecasting budgeted hours.Have awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.
Qualifications
• • Bachelor’s Degree in life sciences/engineering related discipline or related field [Required] Master’s Degree in life sciences/engineering related discipline or related field [Preferred]
Ph.D. in life sciences/engineering related discipline or related field [Preferred]Typically requires 1- 3 years of highly relevant experience and related competency levels [Required]Equivalent combination of education, experience, and training
Knowledge, Skills and Abilities:Experience with FDA/EU MDR/ EU IVDR, ISO and CLSI standardsKnowledge of medical device/IVD development.Knowledge or able to quickly adapt to structural and content requirements of medical devices of clinical evaluation plan/report (CEP/CER), Post Market Clinical Follow-up Plan (PMCF Plan), or for IVD Performance Evaluation Plan/Report (PEP/PER), and associated documents including SVR, APR, CPRGood understanding of common statistical principles, and of medical terminology across a range of therapeutic areas.Understand of latest developments, standards, and guidelines of medical devices and/or IVD devices, and eager to prepare a technical documents development for internal trainings.Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.Ability to identify deficiencies, errors, and inconsistencies in a report or regulatory documents.May act as a lead writer in preparing key technical writing documentation, with consistently positive feedback from customers and colleagues.Excellent written and oral communication skills including grammatical/technical writing skills.Excellent attention to detail and accuracy.Communicates clearly, effectively, and confidently with internal and external team members.Able to deliver difficult messages in constructive manner.Quick learner, and demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.Demonstrated abilities in collaboration with others and independent thought.Demonstrates confidence and maturity in most routine technical writing situations.Demonstrates good judgement in requesting input from senior staff.Ability to establish and maintain effective working relationships with co-workers, managers, and clients.Ability to manage multiple tasks and projects.Ability to identify potential issues/risks, consider solutions and raise with the client, with senior colleagues’ guidance and input proactively.Must be highly computer literate and maintain work hours effectively.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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