• Regulatory Affairs / Senior Medical Writer

    BD (Becton, Dickinson and Company)Warwick, RI

    Job #549969827

  • BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.

    Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company.

    The Surgery business unit is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.

    The position of Regulatory Affairs Medical Writer writes and edits clinical and scientific reports including summaries from raw data for submission to regulatory agencies for in-company use, comprehensive literature reviews, exhibits and other projects requiring skill in medical communication. Coordinates and completes the writing of Clinical Evaluation Reports (CERs) to provide clinical evidence that supports the safety and effectiveness of the BDI Surgery products (pre-market and post-market).

    The position of Senior Medical Writer does all of the above, and additionally creates and manages global clinical summaries for BDI Surgery products and supports the global clinical strategies for new and existing products.

    • Primarily focuses on preparing, writing, editing, and reviewing regulatory documents and responses to regulatory authorities (e.g. Notified Bodies, FDA etc). Efforts will center on Clinical Evaluation Reports (CERs) and clinical data reports/summaries in support for all of BDI Surgery's USA and internationally registered products (particularly focused on products with technical files, design dossiers and international dossiers).

    • Work with New Product Development teams, RA specialists and International Business Center RA teams to create new, and update existing CERs. This will include critical review and incorporation of data from published, unpublished and historical clinical investigations.

    • Periodic updating and maintenance of CERs for BDI Surgery products with post marketing surveillance and clinical data.

    • Participates in post-market surveillance activities by leading routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.

    • Organizes and incorporates information, such as references, graphics, tables, and data listings for the creation of large, technical documents.

    • Ensures documents are produced in accordance with procedures, internal and external guidelines.

    • Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence.

    • Independently, critically writes and edits scientifically complex documents for substantial intellectual content.

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

    • Performs MAUDE data base reviews and summarizes content.

    • Coordinates with various departments (e.g. Regulatory, Product Development, Clinical Affairs, Preclinical, R&D and Quality) to access and identify the necessary preclinical, clinical and technical information in support of CERs.

    • Coordinate external medical writing support/needs, as applicable (ie. External contractors).

    • Special projects as assigned.

    • Bachelors of Science required, with emphasis on life science.

    • RA Medical Writer: Minimum of five years’ experience with a B.S. degree or minimum of three years’ experience with a M.S. degree in technical or medical writing, clinical research or other technical related experience in the implantable surgical medical products or related industries.

    • Senior RA Medical Writer: Minimum of 8 years’ experience; with Master’s Degree, minimum of 6 years’ experience or with PhD, minimum of 2 years’ experience in the implantable surgical medical products or related industries required. Clinical or scientific research background required. Experience writing CERs required.

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

    • Excellent English language skills, especially writing and proofreading. Technical/ medical writing is required for this position; minimum of two years experience highly preferred.

    • Clinical or scientific research background required.

    • Knowledge in narrative and systematic literature reviews required. Creativity with interpretation and presentation of data an asset.

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

    • Understanding of statistical data and good data management practices required.

    • Strong oral communication, presentation, project management and prioritization skills.

    • Excellent interpersonal relationships.

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

    • Ability to travel approximately 20% of time.

    • Experience writing CERs, highly preferred.

    • Regulatory experience with medical device registrations preferred.

    • Clinical understanding of soft tissue repair devices, and BioSurgery sealants and hemostatic products would be an asset.

    *Determination of level will be based upon years of experience & demonstrated knowledge/skills.

    BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.

    LI-CC1

    Industry Standard/Category: Medical Device / Regulatory Affairs

    ID: 2017-10968

    Career Level: experienced

    Division Name: Davol Inc.

    External Company Name: C.R. Bard, Inc.

    External Company URL: ~~~

    Street: 100 Crossings Boulevard

    C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.

    We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.

    Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.

    Updated 04/17/2018