BD (Becton, Dickinson and Company) Senior Medical Writer in Tempe, Arizona
Job Description SummaryThis senior position is responsible for the creation of clinical, scientific and regulatory documents while working with a cross-functional team in accordance with the highest quality standards. 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 relevant products globally.
Essential Job Function:
Manage, prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files/dossiers/registrations as required and per applicable SOPs. Manage internal NPD and consultant/ vendor relationships related to completion of clinical evaluation reports. Ensure compliance to the applicable regulations and guidance documents. Budget planning and budget management related to these activities.
Perform gap analyses and revise existing CERs for legacy products against the Medical Device Regulation.
Working with a multifunctional team, authors assigned protocols, final study reports, manuscripts for publication in peer-reviewed biomedical journals, meeting abstracts, internal reports, and presentations.
Generate and track timelines. Follows through on all tasks and ensures quality results.
May develop or revise templates, SOPs, or guidelines for regulatory/medical/clinical documents.
Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies.
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.
Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
Maintains knowledge of current internal and external standards, regulations and technologies related to this function.
Coordinates with various departments (e.g., Regulatory, R&D, Clinical Sciences, and Quality) to access and identify the necessary preclinical, clinical and technical information.
Coordinate external medical writing support/needs, as applicable.
Provides mentoring/coaching of new hires and/or junior associates, where appropriate.
Basic Skills/Competencies Required:
Must have excellent writing skills and the ability to communicate correctly and persuasively in English, and to use medical terminology accurately.
Requires in depth working knowledge of Microsoft Office Products and ability to manage multiple projects, interact with multi-disciplinary teams, and work independently with minimal supervision.
Ability to quickly acquire and apply understanding of therapeutic areas, medical device portfolios, business objectives, technical skills, clinical data/evidence.
Ability to use judgment based upon standards and polices and meeting timelines.
Good problem-solving and analytical skills. Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project.
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.
Experience writing CERs, highly preferred.
Understanding of current regulatory and clinical requirements (e.g., European clinical requirements, including MEDDEV 2.7.1), highly preferred.
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.
Establishes rapport and collaborates with other (internal and external) team members; builds constructive and effective relationships.
Education and/or Experience Required:
Bachelor’s degree or advanced degree preferred in technical area such as biology, chemistry, engineering or medical-related field.
Minimum of 7 years of medical writing experience in the biotechnology industry. Or Master's degree with 4 years of medical writing experience in the biotechnology industry.
Proficiency in basic computer systems: MS Outlook, Word, Excel and PowerPoint.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.
Primary Work LocationUSA AZ - Tempe BPV Building 3
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