Job Description

Summary



We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health\xe2\x84\xa2 is our Purpose, and it\xe2\x80\x99s no small feat. It takes the imagination and passion of all of us\xe2\x80\x94from design and engineering to the manufacturing and marketing of our billions of MedTech products per year\xe2\x80\x94to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you\xe2\x80\x99ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Position Summary:

This position is a limited term assignment that will include benefits such as medical, health, dental, and 401k. Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy and is anticipated to last approximately through September 30, 2024, with an opportunity for a full-time position thereafter.

The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) to support BD product registration efforts in the EU market. The candidate will lead CEP and CER writing activities and work closely with other departments and functions to ensure the development of high-quality documents in alignment with project timelines and priorities.

This role provides flexibility to work remotely.

Essential / Key Job Responsibilities:

Perform clinical evaluation, including planning, identification, appraisal, analysis, and reporting of clinical data. Prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files/dossiers/registrations as required and per applicable SOPs. Ensure compliance with the applicable regulations and guidance documents.

Coordinate with various departments (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to assess and identify the necessary preclinical, clinical, and technical information.

Perform gap analyses and revise existing CERs for legacy products against the EU Medical Device Regulation.

Generate and track timelines. Follow through on all tasks and ensure quality results.

Develop or revise templates, SOPs, or guidelines for regulatory, medical, and clinical documents.

Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies.

Participate in post-market surveillance activities by leading routine systematic literature reviews (e.g., screen articles against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for specific medical device groups or sub-groups.

Organize and incorporate information, such as references, graphics, tables, and data listings, for the creation of robust and compliant technical documents.

Critically write and edit scientifically complex documents with substantial intellectual content.

Maintain knowledge of current internal and external standards, regulations, and technologies related to this function.

Required Qualifications:

Excellent writing skills and the ability to communicate correctly and persuasively in English and to use medical terminology accurately

In-depth working knowledge of Microsoft Office products

Ability to manage multiple projects, interact with multi-disciplinary teams, and work independently with minimal supervision

Ability to quickly acquire and apply understanding of therapeutic areas, medical device portfolios, business objectives, technical skills, and clinical data/evidence

Ability to use judgment based upon standards, policies, and meeting timelines

Good problem-solving and analytical skills; anticipate problems, issues, and delays; proactively look to minimize the impact on the project

Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users

Knowledge of narrative and systematic literature reviews; accuracy with interpretation and ability to concisely present data is a must

Excellent understanding of scientific or clinical research and methods

Establish rapport and collaborate with other (internal and external) team members; build constructive and effective relationships

Preferred Qualifications:

Experience writing CERs

Understanding of current regulatory and clinical requirements (e.g., European clinical requirements, including MDR, MEDDEV 2.7.1)

Education and/or Experience:

Bachelor\xe2\x80\x99s degree (or advanced degree) preferred with a focus in the sciences, a medical-related field, or medical/technical writing plus 1-3 years of medical device experience OR 5+ years of medical device experience

For certain roles at BD, employment is contingent upon the Company\xe2\x80\x99s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD\xe2\x80\x99s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It\xe2\x80\x99s also a place where we help each other be great, we do what\xe2\x80\x99s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you\xe2\x80\x99ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Primary Work Location IND Gurgaon - We Work

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