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Medical Specialist

Apply Now Job ID R-349923 Date posted 10/09/2019

Job Description Summary

Medical Affairs is responsible for ensuring the safety and efficacy of Medication Delivery Solutions (MDS) products worldwide. The Medical Specialist will support this mission by supporting the work required for EU MDR and providing the clinical users’ perspective for new product development and changes / enhancements to current products.

Job Description

The Medical Specialist will participate on multi-functional EU MDR teams and new product development / sustaining engineering project teams (as needed) as the Medical Affairs Core Team Member to ensure that the clinical perspective is provided for EU MDR related activities, new or modified products are safe and effective, meet the needs of clinicians and patients and to understand the need for current and future clinical trials and other requirements in collaboration with the Associate Director /Director, Medical Affairs as required. S/he will maintain clinical expertise related to the products marketed by MDS for the purpose of internal and external education and / or authoritative participation on EU MDR project, product development and sustaining engineering teams. As required, s/he will evaluate collateral materials and labeling to ensure that they reflect best practices, have a demonstrable basis in fact, and have clarity and utility for the healthcare professional and patients. The Medical Specialist will collaborate with the functional management and / or the Business Unit Director, Medical Affairs to ensure alignment to overall Business Unit objectives. S/he will Support Medical Affairs functional management and / or the Business Unit Director, Medical Affairs in developing the Medical Affairs Strategy to support development, approval, and marketing of new or modified products.

Participates on multi-functional EU MDR project teams as a Medical Affairs Core Team Member.

  • Collaborates with Quality, providing Medical /Clinical input into the medical device Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR).
  • Participates on EU MDR Labeling and other EU MDR Project Teams as the Medical Affairs Core Team Member
  • Reviews and provides input into Post Market Clinical Follow-up (PMCF) plans and provides support for the execution of the required PMCF activities.
  • Authors publications, study summaries, Clinical Assessment Reports and ‘White Papers’ to support regulatory submissions and marketing requirements
  • Provides guidance and expertise for clinical evidence generation (safety / efficacy / usability) required primarily for EU MDR
  • Collaborates with Corporate Clinical Development to provide input and support for Clinical Trials with BD products such as for the purpose of Registrations, Claims Support, and Product Validation in support of EU MDR activities.
  • Collaborates with the EU MDR Medical Writers to provide input into EUMDR Clinical Evaluation Reports

Participates on product development and sustaining engineering project teams, as needed, to ensure that new or modified products are safe and effective, meet the needs of clinicians and patients and to understand the need for current and future clinical trials and other requirements in collaboration with the Business Unit Associate Director, Medical Affairs and / or Director, Medical Affairs:

  • Supports functional management and the Business Unit Director, Medical Affairs in developing the Medical Affairs Strategy to support development, approval, and marketing of new or modified products.
  • Collaborates with the product development teams, creates or provides input into risk management assessment and documentation.
  • Provides guidance and expertise for clinical evidence generation
  • Collaborates with Corporate Clinical Development to provide input and support for Clinical Trials with BD products such as for the purpose of Registrations, Claims Support, and Product Validation.
  • Collaborates with the Marketing, R&D and other functions in the development, execution and documentation of product preference studies or surveys and in gathering voice of customer.
  • Collaborates with the project team to provide input into PMS / PMCF activities

Participates in the review and evaluation of customer complaints  related to product issues / functionality:

  • Assists in the follow up to complaints, the investigation of any product quality issues and the assessment and documentation of the potential health risk associated with product complaints and MDRs as directed.

ACR response:

  • Reviews and Evaluates MDS ACRs to identify MA requirements and provides MA assessment, primarily for EU MDR projects

Review Promotional Material / Labeling:

  • Assists in the development and review of product labeling, graphics, instructions for use (IFU) and marketing materials for accuracy, consistency and the existence of supportive data, primarily for EU MDR related activities

Maintains Clinical Expertise:

  • Maintains clinical / medical expertise for products within the Business Unit and their application as well as remains current on pertinent scientific literature, regulations standards and guidelines as it relates to trends in healthcare
  • Brings an understanding of the clinical setting, as it relates to use of BD products, to both internal and external customers
  • Actively maintains clinical acumen through relevant continuing medical / nursing education venues.
  • Provides clinical education opportunities for internal and external customers

May perform other duties as required.

Minimum Requirements:

  • Minimum of a Bachelor’s degree in health related field (Registered Nurse, Nurse Practitioner, MD, DO) required. Advanced degree preferred.
  • Minimum 5 years’ experience in a hospital care clinical setting
  • Basic understanding of statistics and clinical trial design

Preferred Requirements:

  • Previous medical device or pharmaceutical industry experience preferred
  • Proficiency with MS Office applications
  • Proficiency with a PC
  • Excellent interpersonal skills, including the ability to perform well in a highly matrixed environment, and to serve as an effective member of  multidisciplinary team
  • High degree of critical thinking skills
  • Excellent organizational skills.
  • Strong written and verbal communication skills; ability to create and organize technical / medical documentation.
  • Travel 30% worldwide
  • Will be supervised by the Senior Medical Specialist, Medical Affairs Manager, Associate Director or Business Unit Director, Medical Affairs and the VP Medical Affairs for BD Medical / MDS

Primary Work Location

USA IL - Vernon Hills

Additional Locations

Work Shift

NA (United States of America)
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