Medical Writer

3 weeks ago

Gurugram, India BD Full time

Job Description Summary

Job Description

As a Medical Writer, Scientific Affairs - Medical Affairs you will be responsible for the evaluation of clinical data and in the writing/creation of clinical and scientific reports. These documents are used in regulatory submissions to support safety and performance of our products, to help define clinical endpoints for New Product Development Teams, and to aid in the identification of new indications and unmet needs. This role will support the BD Interventional Surgery Business Unit within the Scientific Affairs - Medical Affairs Function. This individual will report to the Manager, Medical Writing within this team. If you would like to part of a talented and dynamic team and love working on challenging projects, come join the BD family

Essential Duties and Position Responsibilities

Independently prepares, writes, and edits documents to support global regulatory submissions and associated communications with regulatory authorities. The primary focus is independent writing of Clinical Evaluation Plans and Reports (CEP/CERs) and associated documentation, such as Post Market Clinical Follow-up (PMCF) Plans and Evaluation Reports and State of the Art literature reviews per the European Union (EU) Medical Device Regulation (MDR). Works with cross functional teams such as Regulatory Affairs, R&D, Post-Market Surveillance (PMS), Quality, and Marketing to create new or update existing CEPs, CERs, and PMCF documents, and support PMS documents. Responsible for critically analyzing and interpreting clinical data (e.g., literature, real world data, clinical trials, etc.) and writing a thorough and accurate analysis of such data in the clinical evaluation documents. Ensures documents are produced in accordance with corporate/ business unit procedures, regulations/ guidance, and medical writing templates and style guides. Provides technical mentorship and guidance to junior level medical writing associates, as applicable.

Qualifications, Knowledge, and Skills Required:

Bachelor's Degree in the sciences with 3+ years of experience in the medical device/ pharmaceutical industry and clinical, scientific, or literature research experience required. Advanced degree in a scientific discipline preferred (e.g., PhD, PharmD, MPH/MSPH, etc.). Published works is a plus. At least 1 year of experience writing Clinical Evaluation Reports (CERs) beginning to end is required. Ability to evaluate complex clinical data sets and write clear, evidence-based summaries about safety and performance of medical devices with impeccable accuracy. Excellent English Language communication skills. Exceptional writing skills, strong grasp of medical terminology and grammar, and ability to quickly learn and write about varied therapeutic areas. Highly skilled in Microsoft Word, Excel, Outlook, and PowerPoint. Thorough knowledge of medical device regulations and guidance, including EU MDR, MEDDEV 2.7/1 Rev 4, MDCG, and IMDRF required. Experience with high risk (Class II and Class III) medical devices preferred. Working knowledge of clinical literature review, clinical research, device development, regulatory requirements, good clinical and data management practices, and scientific or clinical research and methods. Demonstrated expertise conducting literature searches using Embase, PubMed, Medline, or other similar medical literature databases. Experience with DistillerSR a plus. Demonstrated ability to meet project goals within a matrixed environment. Must be able to handle a variety of projects at the same time and complete deliverables on time. Ability to communicate and collaborate in a remote team environment, and also to work independently with minimal supervision. Ability for potential travel (up to 10%).

Primary Work Location

IND Gurgaon - We Work

Additional Locations

Work Shift

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