Medical Affairs Program Coordinator

Date: Jan 15, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3124

 

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.

 

Interventional Urology – NeoTract is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. As part of the Teleflex Interventional Urology business unit, NeoTract’s focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function*1,2. The UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH in men over the age of 45. The UroLift System lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. More than 175,000 men have been treated with the UroLift System in select markets worldwide.** Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. 

 * No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.

** Management estimate based on product sales and average units per procedure

  1. Roehrborn, J Urology 2013 LIFT Study
  2. McVary, J Sex Med 2014

Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.

Position Summary

The Medical Affairs Program Coordinator assists and supports the Medical Affairs team with program execution and documentation maintenance.  As an integral member of the Medical Affairs team, this position partners closely with members of Clinical, Scientific and Medical Affairs, Professional Education, Commercial teams and various vendors on key projects, including a focus on the UroLift Center of Excellence program. This position requires excellent organizational and communication skills, a clear understanding of regulatory compliance around interactions with medical professionals, high-proficiency in MS Office and other applications, especially Excel, and the ability to adapt to changing priorities in a fast-paced environment.

Principal Responsibilities

•    Participate in development of and maintain documentation for and tracking of designation and re-designation requirements for the UroLift Center of Excellence program 
•    Participate in evaluation and implementation of software applications to support Medical Affairs programs
•    Work with the Medical Affairs team to respond to provider and patient inquiries in a timely fashion, escalating inquiries as necessary based on regulatory requirements and Standard Operating Procedures. 
•    Ability to interpret and apply concepts from general business documents, technical procedures and governmental regulations. 
•    Work with the Medical Affairs team to monitor, evaluate and improve department and program processes over time
•    Perform other tasks as assigned.
•    Respect and participate in our culture being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

•    Bachelor’s degree in a healthcare related field (E.g.: Medical Biotechnology, Healthcare Quality Improvement, RN); or equivalent medical device or pharmaceutical experience.
•    Minimum of 2 or more years of experience in a regulated healthcare industry environment (such as medical device, pharmaceutical or digital health)
•    Experience in software implementation and quality improvement/ implementation science methods, strongly preferred
•    Experience using a CRM and/or document review or similar system, preferred
 

Specialized Skills / Other Requirements

•    Extremely organized, detail-oriented, with the ability to meet deadlines and deliver on commitments 
•    Capable of performing duties in compliance with, both:
o    NeoTract Standard Operation Procedures and work instructions
o    FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which NeoTract complies.
•    Strong customer-focused communication skills, with the ability to respond to verbal and written inquiries for all levels from physicians to potential patients
•    Ability to apply mathematical and statistical concepts in practical situations to interpret information.
•    Ability to recognize potential obstacles and work to resolve them within set timelines, understand how to prioritize and multitask in a fast-paced environment.
•    Ability to adapt to changing work priorities, maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal contacts
•    Comfort with scientific and research methodology, medical device regulations and guidelines
•    Self-motivated, able to learn new processes quickly and take pride in work output.
 

 

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: 262-439-1894.

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.

© 2020 Teleflex Incorporated. All rights reserved.


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland