Specialist, Medical Affairs

3 weeks ago

Franklin Lakes, United States BD Full time

**Job Description Summary**: The Specialist, Medical Affairs for Post-Market Surveillance (SMA-PMS) for Specimen Management (SM), Medical Affairs (SA) is responsible for post-market reporting compliance activities. This position is accountable for coordinating and contributing to the SM post market surveillance reports and ensuring alignment with US, EU, Canada and other regional/country regulations through the implementation of an efficient and effective post-market reporting process. This position is also responsible for assisting in the management and maintenance of proactive customer quality response activities for MA for SM products.

The SMA-PMS demonstrates understanding of technical/scientific principles applicable to in vitro diagnostics and those of associated disciplines (such as R&D, Regulatory Affairs, Quality Assurance, or Project Management). The Specialist, Medical Affairs represents the interest of the patient and the health care worker and has basic understanding of patient safety and product safety and risk assessment.

The SMA-PMS has working knowledge of international regulations and BD policies and procedures and moderate knowledge of and familiarity with BD products, product development process, ISO standards, FDA regulations, and IVD-R.

We are** the makers of possible**

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a **maker of possible** with us.

**Duties and Responsibilities**:

- Works with manager to understand full needs of Medical Affairs (MA) function as it relates to Post Market Surveillance (PMS) Program and annual Post Market Surveillance activities (PMS Plan and Periodic Safety Update Report, PSUR) for Specimen Management (SM) MA, SM products (Laboratory Specimen Management, Specimen Acquisition & Emerging Specimen Management).
- Understands the methodologies required for ongoing post market surveillance
- Implements processes for acquiring, managing, analyzing, interpreting, and reporting Post Market Surveillance data necessary to support PMS reports and PSURs as directed by manager
- Coordinates with QA/RA departments to facilitate completion of PMS and PSUR reports for each product family
- Supports Safety/Risk management activities and updates Health Risk Assessments and Benefit Risk Assessments for legacy DS products. Duties may extend to MA representation for Situation Analysis and Health Risk Analysis deliverables
- Conducts literature search reviews for specified products, and reviews and screens resulting scientific papers for inclusion
- Maintains and updates SM MA Summary of Safety & Performance
- Duties may extend to supporting IVDR Technical File deliverables for new products
- Creates coherent, professional documentation and correspondence of moderate complexity. Is able to draw conclusions from primary and other written and/or verbal sources, present, and/or act on them effectively. Is effective when speaking among peers, team members and functional or Business Management. Work product may require limited review by managers from technical or stylistic point of view.
- Recognizes potential problems and takes preventive steps. Recommends solutions for more complicated or ambiguous issues for consideration.
- Manages multiple projects with ability to organize and prioritize assignments and effectively manages multiple tasks as assigned.
- Manages most activities without supervision. Interactions with management involve weekly or more frequent updates on activities, discussion of issues, proposals for resolution.
- Reviews work for accuracy and follows up with cross functional data owners for clarification as required
- Ensures that accurate, high-quality reports are compiled and reviewed in a timely manner per project timelines and workload demands, and are in compliance with regulatory requirements
- Asserts own ideas and persuades others. Fosters collaboration among team members.

**Qualifications**:

- Excellent writing skills, summarization skills, and demonstrated accuracy in documentation/record-keeping practices; technical, scientific writing experience or publication history a plus
- Working knowledge of Quality Assurance, Regulatory or Quality compliance activities in a medical device or similar industry a plus
- Strong inter-department coordination skills, time management, and activity management required
- Familiarity with in vitro diagnostics in a clinical or academic setting and

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