Job Description Summary

Reporting to the Clinical Sciences Manager or Senior Manager, the Clinical Sciences Specialist ensures efficient and compliant clinical documentation for UCC products throughout the product development lifecycle. The Clinical Sciences Specialist demonstrates developed skills and knowledge in the areas of EU MDR, systematic literature searches, clinical data extraction and analysis, and medical writing. The Clinical Sciences Specialist is accountable for setting their own work direction, prioritizing, and completing deliverables. The Clinical Sciences Specialist function strives to increase the value and impact of Medical affairs activities through the development and maintenance of required clinical documentation from early development through post-market. Clinical documentation includes Clinical Evaluation Plans, Clinical Evaluation Reports, Post-Market Clinical Follow-up Plans, Post-Market Clinical Follow-up Reports, Clinical Impact Assessments, and input for Post-Market Surveillance Plans and Reports.

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. 

RESPONSIBILITIES:

• Responsible for the development and maintenance of clinical documentation in accordance with the European requirements of MEDDEV 2.7.1 Rev 4 and EU MDR, MDSAP, FDA, other applicable regions, as well as internal QMS requirements.

• Participates as clinical documentation writer, MA representative for PMS Project Teams, EU MDR Remediation Teams, Audit-related tasks, and other clinical documentation related responsibilities as required.

• Responsible for tracking status of all assigned tasks and reporting metrics to senior management as requested.

• Participates in updates and revisions to all applicable forms and SOPs in order to maintain compliance to EU MDR, MEDDEV 2.7.1, Rev. 4 requirements, Quality System Regulations, ISO Requirements, International Regulations, FDA Regulations and Corporate/Division policies and procedures.

• Liaison with the MA Specialist PMCF Lead to ensure accurate and adequate recommendations for any needed PMCF activities.

• Liaison with the MA Specialist SSCP lead to ensure accurate and on-time completion of Summary of Safety and Clinical Performance (SSCP) functional reviews.

• Supports and contributes to applicable regulatory submissions and responses to regulatory authorities as needed.

REQUIRED EXPERIENCE & EDUCATION:

• College / university graduate or equivalent experience required.

• 1+ years of Medical Affairs experience preferred

• 1+ years of medical writing experience preferred.

DESIRED KNOWLEDGE, SKILLS AND ABILITIES:

•  Understanding of systematic literature searches preferred

• Strong understanding of MEDDEV 2.7/1 Rev 4, MDD, and EU MDR.

• Must have strong written and verbal communication skills.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.  

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift