Medical Affairs is responsible for ensuring the safety and efficacy of Medication and Procedural Solutions (MPS) products worldwide. The Medical Specialist will support this mission by providing the clinical users’ perspective for new product development and changes / enhancements to current products.
The Medical Specialist will serve as the Medical Affairs Core Team Member on Product Development and Sustaining Engineering Project Teams. S/he will maintain clinical expertise related to the products marketed by MPS for the purpose of internal and external education and / or authoritative participation on 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 Medical Affairs Manager, Medical Resources Manager, under the supervision of the Associate Director and / or Medical Director of the Business Unit to ensure alignment to the overall Business objectives.
Participates on multi-functional product development and sustaining engineering project teams as the Medical Affairs Core Team Member, 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 Medical Affairs Associate Director and or Medical Director for the Business Unit:
- Supports the Senior Medical Affairs Specialist, Medical Resources Manager, Medical Affairs Manager, Associate Director or Medical Director for the Business Unit 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.
- Authors publications, study summaries, Clinical Evaluation Reports and ‘White Papers’ to support regulatory submissions and marketing requirements
- 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.
- In conjunction with Marketing Core Team member, will develop the Short Term Post Market Surveillance Plan and Protocol.
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.
- Reviews and Evaluates MPS ACRs to identify MA requirements and provides MA assessment
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
Maintain Clinical Expertise:
- Maintains medical expertise for products within the Business Unit and their application as well as remain current on pertinent scientific literature, regulations standards and guidelines as it relates to d trends in healthcare
- Brings an understanding of the clinical setting as it relates to use of BD products to both internal and external customers
- Assists in the development of key opinion leaders and identification of experts for products and services within the Business Unit through interaction with outside clinicians
- 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
Bachelor’s degree or higher in health related field (Registered Nurse, Nurse Practitioner, MD, DO)
- Microsoft applications proficiency
- 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.
- Minimum 5 years’ experience in a hospital care clinical setting
- Previous medical device or pharmaceutical industry experience preferred
- Basic understanding of statistics and clinical trial design
- Travel 30% worldwide