Clinical Project Specialist, PMS (Eastern Time Zone Remote Optional)
Job Description SummaryThe Clinical Project Specialist for Post-Market Surveillance (CPS-PMS) for Integrated Diagnostic Solutions (IDS), Medical Affairs (MA) is responsible for post-market reporting compliance activities. This position is accountable for coordinating and contributing to the IDS 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 IDS products.
The CPS-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 Clinical Project Specialist 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 CPS-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.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Duties and Responsibilities:
Works with manager to understand full needs of 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 IDS MA, legacy DS products (Microbiology, Molecular, Women’s Health & Cancer, POC).
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 IDS 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.
Excellent writing skills, summarization skills, and demonstrated accuracy in documentation/record-keeping practices; technical, scientific writing experience or publication history a plus
Knowledge, understanding and interpretations of FDA regulations, ISO standards, EU MDR/IVDR and other industry standards for medical devices as they apply to PMS reporting 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 knowledge of medical/technical terminology
Familiarity with BD products a plus
Strong critical thinking, strategic assessment, and analytical and problem solving skills
Excellent verbal and written communications, professionalism, and interpersonal skills
Ability to deal w/ambiguity
This position reports to Medical Affairs management located in Sparks, MD. This position can be located anywhere in East-Central USA, and may require occasional travel to Sparks, MD.
Minimum of a bachelor’s degree required in biomedical sciences, the life sciences, clinical, laboratory or other relevant technical areas. Professional certification is a plus.
Minimum 1 year experience in Quality, Medical Affairs, Clinical research in microbiology or molecular biology, biomedical librarian, or related discipline to demonstrate the qualifications.
Location: The ideal candidate will be eastern time zone with the ability to travel on the rare occasion for training or business critical needs.
For many roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
Primary Work LocationUSA MD - Sparks - 7 Loveton Circle
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