Regulatory Affairs Medical Writer
Job Description Summary
The Regulatory Affairs Medical Writer writes clinical and scientific reports including summaries fromsummarizeddatafor submission to regulatoryagencies for in-company use, comprehensive literature reviews, exhibits and other projects requiring skill inmedical communication.Contributes tothe writing of Clinical Evaluation Reports (CERs)and Summary of Safety and Clinical Performance (SSCPs)toprovide clinical evidence that supports the safety and efficiency ofBDISurgeryproducts(pre-market andpost market).
Essential Duties and Position Responsibilities
Responsible for participating in thepreparing, and writing, regulatory documents.Efforts will center on Clinical Evaluation Reports (CERs)and clinical data reports/summaries in support for allBDI Surgical Business Unit Products.
Sits in on meetings with New Product Development teams, RA specialists and International Business Center RAteams to update existing CERs. This will include critical review and incorporation of data frompublished, unpublished and historical clinical investigations.
Participates in periodic updating and maintenance of CERs for Davol products with post marketing surveillance andclinical data.
Works collaboratively with PMS Group in supplying literature analysis for post market surveillance results.
Organizes and incorporates information, such as references, graphics, tables, and data listings for thecreation of large,clinicaldocuments.
Preparation of documents in accordance with procedures, internal and external guidelines.
Preparation of documents in accordance with regulatory standards, guidelines and regulations.
Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, businessobjectives, clinical data/evidence.
Writes and editsmedium complexity scientific and regulatory documents
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
Qualifications, Knowledge, and Skills Required:
Bachelor’s Degree in a scientific, regulatory orclinical field required
Minimum3years of experience in the implantable surgical medical products or related industries.
Clinical understanding of soft tissue repair devices, andBio-surgerysealants and hemostatic products
Working knowledge of clinical research, device development processes, regulatory requirements, goodclinical and data management practices.
Experience with Microsoft Word, Excel and PowerPoint
Excellent English language skills, especially writing and proofreading.
Clinical or scientific research background required.
Experience writingClinical Evaluation Reports and literature summary reports
Knowledge in narrative and detailed literature reviews required. Creativity with interpretationand presentationof data an asset.
Excellent understanding of scientific or clinical research and methods required.
Basic Knowledgeof statistical data and good data management practices required.
Strong verbal communication, presentation, project management and prioritization skills.
Excellent interpersonal relationships.
Regulatory experience with medical device registrations preferred.
Must be able to handle a variety of projects at the same time.
Ability for potential travel as needed (up to10%).
Corporate Legal and Regulatory Affairs
Health Ministries, Notified Bodies, and regulatory agencies (i.e.FDA)
Scope and Impact of Position:
This position will generate and maintain clinical evidence for Davol’s products. This includes a growingline of mesh prosthetics, biologic implants, and fixation systems to complement innovative techniques foringuinal, ventral and other hernia procedures, plus a range of products for laparoscopy, pulsed lavage andwound management. In addition to this extensive suite of products, theBio-surgeryfranchise is delivering agrowing line of enhanced sealants and hemostatic products to complement surgical techniques across,thoracic, cardiovascular and other surgical specialties.
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.
Primary Work LocationUSA RI - Warwick
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Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
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