08/12/2017 | Chester, NY
- Design, plan and conduct clinical research trials (prospective and retrospective for pre- and post-market studies) by executing all relevant activities. Interact with study coordinators and investigators ensuring compliance with study protocols, FDA and international regulations, IRB and/or Ethics Committees requirements in order to achieve overall clinical objectives.
- Act as Medical Science Liaison (MSL) in communications and interactions with Key Opinion Leaders (KOL’s), specialty pharmacists, and clinical nurses for product information exchanges, education, collaborations for publications and medical information. Support sales force with updated medical information and training.
- Work with RA/QA for post-market product safety surveillance, MDR reportability evaluation and MDR reporting process as required by the FDA and international regulatory agencies.
Essential Job Functions
- Under the direction of the Chief Medical Officer, initiate and manage clinical research projects.
- Oversee patient screening and enrollment at assigned clinical study sites.
- Prepare and monitor ongoing compliance to study protocols.
- Work with investigators to quickly and effectively resolve discrepancies.
- Review source documentation, case report forms, and data reports for accuracy to ensure timely submission of documentation.
- Perform site training to ensure compliance to the Investigation Plan.
- Develop materials for clinical training sessions.
- Coordinate meetings with site coordinators and investigators.
- Prepare written reports including whitepapers for publication.
- Ensure accurate inventory of investigative devices.
- Routinely recognize problems and recommend corrective and preventive action.
- Support development of the Design and Process FMEA.
- Identify hazards and mitigating risks associated with identified hazards in Design and Process FMEA and determine severity of the harms associated with identified hazards.
- Evaluate product history data based on customer complaint records, results of controlled investigations and published literature for the device or similar devices, if applicable.
- Attend relevant scientific and/or medical meetings. Present clinical poster boards for medical meetings and present clinical study results to customers.
- Act as MSL between KOLs, customers, patients and sales to exchange, collect, educate medical information related to safety and effectiveness of RMS.
- Perform safety evaluation for customer complaints for MDR reportability and actual reports to US FDA and international regulatory agencies.
- Travel up to 30%.
Education, Training, Skills and Experience Requirements:
- Local candidates only; No relocation available.
- Minimum 5 to 7 years’ experience in clinical trials, within Medical Devices preferred; former MSL experience is a plus.
- Requires a Bachelor’s of Science, RN or BSN degree or equivalent; M.D. or Ph.D. are a plus.
- Knowledge of FDA regulatory requirements relating to the conduct of clinical studies (pre- and post-market studies).
- Resolve problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Excellent verbal and writing skills along with good interpersonal and communication skills.
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore employees assigned may be required to perform additional job tasks required by the manager.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
RMS Medical Products provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, marital status, pregnancy, parental status, national origin, ethnic background, age, disability, political opinion, social status, veteran status, union membership or genetics.
Repro-Med Systems, Inc., operating as RMS Medical Products, is a leading developer and manufacturer of medical devices and supplies. RMS manufactures medical devices used in emergency care, hospital settings, nursing homes, other medical facilities and home care. The Company’s principal products are the FREEDOM60® Syringe Infusion System and the RES-Q-VAC® Emergency Medical Suction System. In 2011, the company received FDA approval to market in the US its HIgH-Flo Subcutaneous Needle Sets™. The company maintains offices, manufacturing facilities, and warehouse space in Chester, New York. www.rmsmedicalproducts.com
All positions offer opportunity for advancement. If you have the skills and are seeking a challenging growth opportunity, please e-mail your cover letter, resume and salary requirements to email@example.com or fax to 845-469-5518.
RMS offers a competitive salary and benefits package, including medical, dental, LTD and 401(k).