Job Description :
Hello All,
My name is Alex Thomas and I am a Staffing Specialist at VedaInfo Inc. I am reaching out to you on an exciting job opportunity with one of our clients.
Job Title: Nephrology Nurse (Renal Support Specialist)
Client: BAXTER
Project Duration: 12 Months contract
Project Location: Deerfield, IL
Job Description:
The NEPHROLOGY NURSE CONTRACTOR will provide clinical expertise related to renal disease and treatment; specifically, Peritoneal Dialysis (PD) and Hemodialysis (HD) therapy and products. This nurse will be responsible to review and edit various documents describing the clinical use, benefits and risks of renal products.
This nurse will review and edit documents required for global regulatory submissions for PD and HD medical devices, such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CERs), Post Market Surveillance Plans (PMSP) and Reports (PMSR, PSUR), Summaries of Safety and Clinical Performance (SSCP) Clinical, and Risk Management Plans (RMP) and related files.
This nurse will also work with global cross- functional teams including; Clinical Development. Medical Affairs, Quality, Patient Safety and Post Market Surveillance, Regulatory, Marketing, Manufacturing, and Labeling.
This position will report directly to the Nurse Manager/Project Manager in Global Renal Medical Affairs and will require approximately 40 hours per week Monday-Friday with early and late hours occasionally required.
Essential Duties and Responsibilities:
1. Review and edit regulatory, safety, and quality documents outlined above and as needed
2. Provide guidance and answers to clinical/medical questions from internal teams regarding renal products and therapies
3. Maintain expert knowledge on all Renal products.
4. Work within product and project teams to define deadlines, monitor progress, and deliver required outputs in a timely and professional manner
5. Ensure that documents required to support regulatory and safety filings are accurately prepared.
Qualifications:
1. The current registered nursing license in the state they reside in.
a. respond to new demands and challenges while working effectively in ambiguous situations with changing priorities based on business needs
b. work in a multicultural and cross-functional environment to facilitate discussion and resolution of different views
2. Strong Interpersonal Communication Skills; including excellent verbal/written communication skills
3. Strong Microsoft Office skills required (such as Microsoft 2016 Word and Outlook, Excel 2016, and PowerPoint)
4. Demonstrated ability to search for and analyze clinical literature
Education and/or Experience:
1. Bachelor of Science in Nursing preferred with at least 5 years or more of renal nursing experience.
2. Recent and substantial acute and chronic peritoneal and hemodialysis experience (within last 3 yrs.
3. Renal product knowledge/clinical experience preferred.
4. Experience responding to regulatory audits (state or network
5. Residency in Northern IL or Southern Wisconsin preferred.
Interview Platform: Phone followed by onsite for local candidates/ phone followed by Video WebEx for non-local candidates
Note: This is an On-Site role
Should you be interested, please send me a copy of your resume.
Alex
Technical Recruiter
Office EXT: 133
Ph
E-Mail:
Website:
Vedainfo Inc., 3868 Carson Street, Suite 204, Torrance, CA 90503