BD (Becton, Dickinson and Company) Jobs

Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to 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’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

This position is a limited term assignment which will include benefits such as (medical, health, dental, 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 May 31, 2024.

Summary/Purpose of the Position

As a Medical Writer, 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, they are used to help define clinical endpoints for our 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 Medical Affairs Function, specifically the Global Evidence Generation and Dissemination Team (Global EGD). This individual will report to the Manager, Medical Affairs within this team. If you would like to part of a versatile and dynamic team and love working on bold projects, come join the BD family!

Essential Duties and Position Responsibilities:

• Independently prepares, writes, and edits clinical documents as it pertains to global regulatory submissions, and associated communications with the regulatory authorities (e.g., Notified Bodies, FDA, etc.). Efforts will center around Clinical Evaluation Plans and Reports (CEP/CERs) to support both European Union and Global submissions, SSCPs and clinical data reports/summaries in support of all BDI Surgery products.

• Works with cross functional teams including but not limited to product development, Regulatory Affairs, R&D, Post-Market Surveillance (PMS), and Quality to create new or update existing CERs, SSCPs, reports to support expansion of indication/claims.

• Perform systematic literature reviews and derive safety & performance outcomes to support clinical evaluation, clinical evidence mapping, evidence generation planning, and clinical trial design.

• Responsible for critically analyzing and interpreting clinical data (e.g., literature, real world data, clinical trials, etc.) and compiling reports to support evidence generation and dissemination.

• Provides results from systematic literature reviews to support post-market surveillance activities such as PMS Reports and Periodic Safety Update Reports (PSURs).

• “Ensures documents are produced in accordance with corporate/BU procedures, and regulatory standard/guidance.”

• Provides technical mentorship and guidance to junior level medical writing associates.

Qualifications, Knowledge, and Skills Required:

• Bachelor’s Degree in the sciences with 5 + years’ experience in the medical device/pharmaceutical industry. Advanced degree in a scientific subject area, preferred (e.g., PhD, PharmD, MPH/MSPH, etc.).

• Demonstrated ability of writing Clinical Evaluation Reports (CERs) beginning to end is required.

• Extensive experience with high risk (Class II and Class III) medical devices.

• Extensive knowledge of clinical research, device development processes, regulatory requirements, good clinical and data management practices.

• Excellent understanding of scientific or clinical research and methods required.

• Extensive knowledge with EU MDR, MEDDEV 2.7.1 Rev 4, GSPR, MDCG, and IMDRF required.

• Clinical or scientific research background required. Published works is a plus.

• Expertise in conducting literature searches using PubMed, Medline, or other similar medical literature databases. Experience with DistillerSR a plus.

• Proficient in Microsoft Word, Excel, and PowerPoint.

• Excellent English Language skills, especially in writing and proof reading.

• Proven ability to meet project goals within a matrixed environment.

• Strong oral and written communication skills.

• Excellent project management and social skills.

• Must be able to handle a variety of projects at the same time.

• Ability for potential travel (up to 10%).

For certain roles at BD, employment is contingent upon the Company’s 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’s 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’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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’ll 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 https://bd.com/careers

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.

PDN

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Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift

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.