Associate / Regulatory Affairs Medical WriterBecton, Dickinson and Company - Warwick, RI
Associate / Regulatory Affairs Medical Writer
Bard Davol Inc.,
a subsidiary of C. R. Bard, Inc., located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. We focus our business on key surgical specialties, including Soft Tissue Repair, Surgical Fixation, Biomaterials and Orthopedic/Wound Management Irrigation.
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.
Davol headquarters 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.
Summary of Position with General Responsibilities
The position of Associate / 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 Davol products (pre-market and post-market).
Essential Job Functions
Associate Regulatory Affairs Medical Writer
Primarily focuses on preparing and writing 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 Davol’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 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 This will include critical review and incorporation of data from published, unpublished and historical clinical investigations.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 Davol products with post marketing surveillance and clinical data.
Participates in post-market surveillance activities by participating in 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.
Preparation of documents in accordance with procedures, internal and external guidelines.
Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence.
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.
Works 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.
Works with external medical writing support/needs, as applicable (i.e. External contractors).
Special projects as assigned.
Regulatory Affairs Medical Writer
All of the above as outlined under Associate Regulatory Affairs Medical Writer.
Prepares, writes, edits and reviews regulatory documents and responses to regulatory authorities (e.g. Notified Bodies, FDA etc.).
Creates new CERs.
Leads routine systematic literature reviews.
Independently writes and edits scientifically complex documents.
Bachelors of Science required, with emphasis on life science.
Associate RA Medical Writer
: Minimum of one to three years’ experience with a B.S. degree in technical or medical writing, clinical research or other technical related experience in the implantable surgical medical products or related industries.
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.
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.
Additional Desirable Qualifications Skills and Knowledge
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.
Education and/or Experience
Determination of level will be based upon years of experience & demonstrated knowledge/skills.
Davol Inc. and C.R. Bard, Inc. are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.
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
BD (Becton, Dickinson and Company)
BD (Becton, Dickinson and Company) Jobs
10 days 8 hours ago
applyAssociate / Regulatory Affairs Medical Writer Becton, Dickinson and Company - Warwick, RI, United States
BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. BD is headquartered in the United States and has offices in more than 50 countries worldwide.
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