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Senior Medical Writer

Apply Now Job ID R-332972 Date posted 03/15/2019

Locations

Tempe, Arizona

Job Description Summary

This 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.

Job Description

Essential Job Function:

  • Coordinates and completes the writing of Clinical Evaluation Reports (CERs) and Post Market Clinical Follow-up (PMCF) Plans and Reports per MEDDEV 2.7.1 Rev 4 standards to provide support for globally medical products.

  • Manage, prepare, and update Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files/dossiers/registrations per applicable SOPs.  Ensure compliance to applicable regulations and guidance documents.
  • Participate 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.
  • Organize and incorporate references, graphics, tables, and data listings for the creation of large, technical documents.
  • Write and edit scientifically complex documents
  • Maintain knowledge of current internal and external standards, regulations and technologies related to this function.
  • May develop or revise templates, SOPs, or guidelines for regulatory/medical/clinical documents. Coordinate with various departments (e.g., Regulatory, R&D, Clinical Sciences, Clinical Affairs and Quality) to access and identify the necessary preclinical, clinical, and technical information.

Basic Skills/Competencies Required:

  • Must have excellent writing skills, the ability to communicate persuasively in English, and be able to use medical terminology accurately.
  • Experience writing CERs and/or PMCF plans and reports based on current regulatory and clinical requirements (MEDDEV 2.7.1, rev.4) highly preferred
  • 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 and meet 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 a clear, concise, and scientifically accurate narrative
  • 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 2 years of experience writing CERs.
  • Proficiency in MS Outlook, Word, Excel, and PowerPoint.

Physical Demands:

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. 

Work Environment:

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 Location

USA AZ - Tempe BPV Building 3

Additional Locations

Work Shift

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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