Medical Affairs Specialist

Date: Feb 6, 2024

Location: Wayne, PA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 9730 

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Global Functions The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Medical Affairs Specialist leads and participates in several dynamic Medical Affairs workstreams.  This position will play a key clinical role in supporting our patients, internal colleagues, and customers, contributing clinical expertise, and leading and supporting processes in areas such as:  
•    Promotional and other materials review 
•    Risk Management activities, including patient safety evaluation, documentation of risk/harm stratifications. 
•    Managing requests for medical information for the Interventional Urology business unit.
•    Processing and determinations of complaints in clinical studies and real-world situations in collaboration with associated teams. 
•    Responses to patient inquiries and surrounding processes, participation in special projects and other duties as assigned.
As an integral member of the Clinical Medical Affairs team, this role will enable you to utilize and grow your skills in multi-program management, on-going development, and improvement of processes, building strong internal relationships and representing Medical Affairs in activities driven by other departments. This work will rely on your skills in clinical decision-making, project management, medical writing, and process improvement methods. We are looking for someone with a clear understanding of healthcare delivery, and an interest in /exposure to clinical operations and regulatory requirements; strong, customer focused skills and the ability to perform independently in a fast-paced, dynamic environment. 
 

Principal Responsibilities

•    Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data.
•    Manage requests for medical information, utilizing appropriate cross-functional input to create and standardize responses.
•    Collaborate with Clinical Study and real-world complaint handling teams to process, document and adjudicate complaints.
•    Develop, write, and edit medical content and source documents for multiple therapeutic areas for a wide range of topics and events.  
•    Includes performance of comprehensive literature searches to develop in-depth education and in understanding current scientific literature to support of identified product lines and clinical landscapes.
•    Participate in cross-functional Risk Management activities, including but not limited to:
•    Evaluation and input on Health Hazard Analyses in collaboration with Medical Affairs team members
•    Cross-functional development of risk documents.
•    Assessment of medical adverse events and adjudication of clinical and commercial complaints. 
•    Develop, implement, and improve templates and standardization of processes for reportable event follow-up and regulatory submissions. 
•    Perform other duties as assigned.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, 
efficient, high-achieving, and fun!
 

Education / Experience Requirements

•    MD, NP, PA, PharmD, RN, LPN/LVN or equivalent practical experience with at least 7 years of experience in or combination of experience in clinical care, medical device, biotech, hospital administration or pharmaceutical industry (com 
•    Strong customer focused skills with the ability to respond to verbal and written inquiries for all levels including executives, physicians, and patients.
•    Adaptable and welcoming of change and willingness to explore and implement process improvements.
•    Advanced organizational and time management skills
•    Sound clinical decision-making.
•    Understanding of statistics as it relates to clinical studies and interpretation of medical literature. 
•    Experience in project management to drive initiatives forward successfully. 
•    Experience in clinical process improvement is a strong plus.
•    Intermediate level of comfort with Microsoft Office, (including strong experience Excel) Teams/Sharepoint, OneNote, etc. 
•    Basic medical writing
•    Experience in leading by influence.
•    Skills in complex analytic problem solving. 
•    Ability to recognize potential obstacles and work to resolve them within set timelines.
•    Strong interpersonal and relationship building skills.
•    Expertise in scientific and research methodology, medical device regulations and guidelines. 
 

Specialized Skills / Other Requirements

•    Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which NeoTract complies.
•    Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.
•    Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
•    Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
•    The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•    While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

The pay range for this position at the commencement of employment is expected to be between $110,000 - $150,000 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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Working Conditions / Physical Demands

TRAVEL REQUIRED: 5 %

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory
 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.