Job Description Summary

Medical Affairs is responsible for ensuring the safety and efficacy of Medication Delivery Solutions (MDS) products worldwide. The Medical Writer will support this mission by assisting with and / or compiling, reviewing and summarizing, available data to access the safety and efficacy of MDS products worldwide.

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 creativity 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 entrepreneurial 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. 

 

Key responsibilities will include:

• The Medical Affairs Medical Writer will combine their knowledge of science with their understanding of research and writing to present information effectively and with clarity.

• The Medical Writer will focus on scientific medical writing to prepare documents – clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) – for submission to regulatory bodies and post market clinical follow-up (PMCF) plans for medical affairs.

• The Medical writer will collaborate with other functions and with the Senior Medical Writer as vital to ensure accurate and timely completion and review of clinical documents for regulatory submissions.

About you: To be successful in this role, you require:

• Minimum Education Required Associates Degree

• Experience in a relevant Medical Device Industry required.

• Minimum of 3 years writing experience within the Medical Device Industry.

• Certification through the American Medical Writing Association (AMWA) or other relevant association is preferred.

• Outstanding attention to detail.

• Ability to write with scientific accuracy.

• Ability to compile, write, edit, and format documents for submission to regulatory agencies. (Writing samples required)

• Ability to assist with comprehensive literature searches as needed.

• Understanding of MEDDEV 2.7/1 rev4 guidelines and the MDR regulations related to clinical evaluation reports preferred.

• Ability to ensure that all deliverables are in accordance with applicable regulations, standards, and guidelines.

• Excellent written and verbal communication skills.

• Proficiency in MS Office with expertise in Microsoft Word with a special focus on word processing, use of templates, and formatting. Solid understanding of Excel.

• Proficiency with a PC.

• Excellent time management skills, and ability to meet deadlines

• Solid understanding of statistical concepts and techniques.

• Experience in working with collaborative, cross-functional teams.

• Ability to function well both individually and as part of a team.

 

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/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 or