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BD (Becton, Dickinson and Company) Sr. Medical Writer in Tempe, Arizona

Job Description Summary

Job Description

  • Provides mentoring/coaching of new hires and/or junior associates, where appropriate.

  • Manage and maintain project milestones and writing activities to align with business goals.

  • 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.

  • Manage, prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technicalfiles/dossiers/registrationsas 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 forregulatory/medical/clinicaldocuments.

  • 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.

Skills/Experience:

  • Prior project or program management experience.

  • Supervisory or management experience.

  • 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 (advanced degree preferred) in the sciences, a medical-related field, or medical/technical writing

  • Minimum of 5 years of experience writing CERs and Managing Clinical Programs and Resources.

  • Proficiency in MS Outlook, Word, Excel, and PowerPoint.

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.

#LI-PRO

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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