Associate Global Medical Safety Director (Part Time/Remote US)

Position Summary

This role will be to ideate, create, promote, institute and monitor workstreams for patient and medical safety across the global Teleflex portfolio reporting directly to the Global Medical Safety Director. As part of the Clinical and Medical Affairs (CMA) function and in partnership with QARA, this position will work with the entire safety team to ensure that the highest patient safety standards are achieved in accordance with our quality commitments.  This role serves as an adjunctive subject matter and technical expert in an area of acute clinical medical practice, research and medical educational programs regarding safety. This role will have an opportunity to work with a global, cross-functional team to make a meaningful difference in patient care through the incorporation of safe and effective use of products and procedural education into medical practice. This individual will be responsible for providing safety and risk input and guidance, both internally and externally, on complex issues and effective education relating to safety, efficacy, clinical research and scientific exchange for existing product indications, precautions and warnings and new products or unsolicited off-label use of FDA and other Competent Authority cleared products. The position with be responsible for providing reactive and proactive medical and clinical knowledge into the responsible product areas throughout the product life cycle and to develop and deliver proactive and reactive communication to relevant internal and external customers. Providing the safety team input on complex issues, development, and execution of strategy for the CMA function, and co-lead cross-functional complex projects. The role provides an expert medical resource to manufacturing, clinical, sales, marketing, R&D, QA/RA, business development, and customers. The role will influence and affect positive outcomes for patients, maintain and improve safety and efficacy and drive greater product acceptance and utilization. Primary responsibility for key physician related activities, education and oversight of field engagements that support scientific objectives across the globe. This position has a fundamental role in overcoming identified barriers through both peer-to-peer communication, education, clinical research support and guidance to internal stakeholders. Serves as a technical resource to manufacturing, clinical investigators, sales, regulatory, education and marketing representatives; gathers input from cross-functional teams and creates plans and programs that improve the understanding, safe and effective utilization of Teleflex products by clinicians and their patients. 

Principal Responsibilities

Quality Assurance and Regulatory Affairs
•    Provide subject matter expertise for discussions of patient complaints and nonconformance to the development and completion of Risk Evaluations, Health Hazard Evaluations, and Event Investigations Files
•    Direct involvement representing Clinical and Medical Affairs on the Product Safety Review Board.
•    Provide subject matter expertise to the completion of Clinical Evaluation Reports and Plan, Post Market Clinical Follow Up, Summaries of Safety and Clinical Performance, Post Market Surveillance, Risk Management Reports as part of the ongoing proactive and reactive reviews of quality and safety.
•    Provide input and update the Global Harms Reference that will be used for the basis of severity risk for Teleflex.
•    Provide subject matter expertise to the creation and maintenance of 
Process Failure Mode and Effects Analysis (PFMEA), Design Failure Mode
and Effects Analysis (DFMEA), Use Failure Mode and Effects Analysis (UFMEA) and Hazard Analyses for both new and existing devices. 
•    Responsible for UFMEA and the conversion of Hazard Analyses across the entire portfolio to Risk Assessment and Control Tables, with increased complexity to provide detailed description of the harms severities and probability of harm resulting in different severities.
•    Coordinate with Regulatory Department regarding the proper handling of complaints, customer or product failures and safety and efficacy issues 

Research and Development Support
•    Participate as part of the Concept to Commercialization process to 
provide subject matter expertise to multiple New Product Development 
Projects. This extends to ongoing maintenance in Sustaining 
Engineering both for the investigation of complaints and Cost Improvement Projects. 

Mergers and Acquisitions, Legal Support
•    Provide clinical input to the Due Diligence process as part of the M&A Team, and to Legal in relation to a wide range of issues.

Sales & Marketing Support
•    Provide education and training around the safe and effective use of the company’s devices to the sales and marketing teams.  
•    Provide congress/tradeshow support. Answer questions at exhibitions, develop and give presentations, staff medical booth, meet thought leaders and participate in customer events. Further scientific communications domestically and internationally.
•    Lead the development and enhancement of relationships and interactions with key opinion leaders and societies. Develop peer-level relationships and cooperation with external experts and other important decision makers in a consistent way, aligned with the overall company strategy and objectives.
•    Utilize Scientific Exchange to engage in peer to peer education, discussion and utilize to drive clinicians to have better knowledge for implementation of Teleflex products. 
•    Off-label support along with other members of the Clinical & Medical Affairs team for Teleflex products in accordance with Teleflex policy & local legal regulation
•    Adhere to applicable Teleflex IPP’s, Teleflex Code of Ethics, and all Company policies, rules, procedures, and housekeeping standards.
 

Education / Experience Requirements

•    Doctor of Medicine (MD) or corresponding international medical degree equivalent required. Prefer specialty in Anesthesiology, Critical Care, Surgery, Emergency Medicine or other acute medical specialty.
•    Minimum of 5 years of clinical experience practicing in the healthcare environment required
•    Previous experience in a leadership position, managing and developing teams required
•    Experience in literature identification and analysis required
•    Regulatory experience preferred
•    Clinical and Medical Affairs experience preferred
 

Specialized Skills / Other Requirements

•    Strong understanding of medical device market needs and current offerings
•    Ability to critically analyze, interpret and summarize clinical data
•    Ability to network and partner with customers and thought leaders
•    Excellent interpersonal communication (written and verbal) and presentation skills
•    Effective time-management and organizational skills including the ability to coordinate and prioritize multiple projects simultaneously.
•    High attention to detail and the ability to adapt to shifting priorities
•    Established track record of building and maintaining relationships with internal and external customers.
•    Must be scientifically oriented with strong research, logic and reasoning ability
•    Demonstrated ability to conduct business in an ethical manner
•      Strong understanding of scientific principles and statistical methods used to find, analyze and assess clinical studies and appropriately apply data in the application of Teleflex Medical products.
•      Ability to read, understand and abide by company procedures. 
•      Capable of comprehending large amounts of scientific content and 
the ability to define problems, collect data, establish facts, draw valid
conclusions and report on findings concisely. 
•    Ability to work successfully in a home office environment
•    Requires the ability to travel a minimum of 50% including overnight stays and ability to travel internationally.
•    Advanced skills in Microsoft Office Suite including Word, Excel, PowerPoint, Outlook etc.
•    Ability to develop and foster relationships with KOL’s and key business stakeholders
•    Pro-active and results oriented

The pay range for this position at commencement of employment is expected to be between $100,000- $135,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
 

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