Medical Writer

Date: Apr 30, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3849

 

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

This role is central in the development of scientific and medical communications for Interventional Urology, Teleflex Incorporated and will also serve as medical and scientific review or consultation for various internal and external projects and deliverables. The position works closely with cross-functional teams within the organization to communicate accurate, consistent, and timely information regarding products and therapeutic approaches for Teleflex products. This includes leading the update of the clinical evaluation report (CER) and the communication of clinical studies and emerging research through publications and presentations. Additional opportunities may also include contributing to clinical development initiatives, literature reviews and educational resources. This position will be responsible for fostering cross functional relationships including partners in regulatory, marketing and sales. The position will report to the Manager of Scientific Affairs for Interventional Urology. 

Principal Responsibilities

•    Lead the development, implementation, and dissemination of scientific publications and conference podium presentations and provide editorial and written support when needed.
•    Identify KOLs to disseminate clinical data and work directly with authors in preparation for scientific presentations. 
•    Lead the annual update of the IUBU clinical evaluation report (CER), including the literature search, in accordance with EU MDR requirements. 
•    Lead specific cross-functional team projects to disseminate clinical information in various formats including letters to the editor, white papers, and industry sponsored clinical updates. 
•    Provide scientific consultation during clinical study development, strategic product development, engineering activities with R & D, regulatory submissions, and evidence generation plans. 
•    Collaborate in the creation and dissemination of relevant content to meet customer needs and that address education/communication gaps between customers and the sales force. Ensure content is current, accurate, and fair-balanced and guidelines for educating customers on clinical evidence are followed. 
•    Provide medical and scientific expertise by maintaining current familiarity of relevant published literature and communicate updates with appropriate departments; respond to requests for medical information regarding the company’s marketed and pipeline products.
•    Develop and maintain relevant standard operating procedures (SOPs) for publication development processes and tools. Ensure all required documentation is in place for each project.
•    Stay up to date with clinical initiatives/guidelines and current industry practices that pertain to scientific communications.
•    Assist with medical review and other communication-related activities as assigned by the supervisor.
•    As needed, attend national and international conferences to stay current with advancements in the field and contribute to the development of conference coverage reports for internal distribution.
•    Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun! 
 

Education / Experience Requirements

•    Advanced degree, such as a Ph.D., M.D., BSN, or PharmD, with at least 2 years of relevant experience; or Master’s degree with at least 3 years of scientific writing experience; or Bachelor’s degree with at least 5 years of scientific writing experience or equivalent experience.
•    Ability to critically evaluate literature, interpret complex data, write effectively, and articulate information to a variety of audiences
•    Knowledge of clinical research methodology, tools, processes, and regulations
•    Communicates clearly and succinctly both verbally and in writing 
•    Strong knowledge of statistical methods a plus 
•    Ability to develop and foster relationships with KOLs and key business stakeholders
•    Can effectively negotiate with counterparts from cross-divisional functional areas
•    Advanced presentation and computer skills, proficiency in MS Office Suite required 
•    Highly motivated, ability to coordinate and prioritize multiple projects simultaneously and independently.

Specialized Skills / Other Requirements

 

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