Sr. Medical Affairs Specialist (Remote)

Date: Nov 25, 2021

Location: Pleasanton or Remote, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 4972

 

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 Senior Medical Affairs Specialist leads and participates in a number of 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.
  • KOL and HCP relations: Development, collaboration and management of advising, board and other activities.
  • 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 position 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, 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 assure 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.
  • Manage operations for Medical Advisory Boards in collaboration with the Associate Medical Director and other team members.
  • 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 three (3) years of experience in the medical device, biotech, hospital administration or pharmaceutical industry.
  • Experience in project management to drive initiatives forward successfully
    • Experience in clinical process improvement is a strong plus.

Specialized Skills / Other Requirements

 

  • 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
  • Organizational and time management skills
  • Sound clinical decision-making
  • Understanding of statistics as it relates to clinical studies and interpretation of medical literature.
  • Intermediate level of comfort with Microsoft Office, (including strong experience Excel) Teams/Sharepoint, OneNote, etc.
    • Experience with Visio or other mapping applications is a plus.
  • Basic medical writing
  • Ability to demonstrate experience in leading by influence.
  • Ability to demonstrate 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.

 

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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland