Medical Records Field Rep
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Deerfield, IL 60015
Client Position Title: Renal Support Specialist
Position Number: 326716
Location: Deerfield, IL 60015
Desired Skill Set:
Document Review, Documentation, Medical device, Nursing
Position Description:C2C is not available
Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.
Renal Support Specialist
Requirement Number: 8919
Contract Start: ASAP
Duration or End Date: 12 months
Location: Deerfield, IL 60015
Official Job Title: Nephrology Nurse/Clinical Contractor
The Nephrology Nurse/Clinical Contractor will provide clinical expertise for the Renal Peritoneal Dialysis (PD) Therapy. The Clinical Consultant will utilize his/her therapeutic knowledge and expertise of PD dialysis therapies to contribute to the development of new renal products for the global market. This position will work collaboratively with the Medical Manager in the Renal Therapeutic Area.
Additionally the Nephrology Nurse/Clinical Contractor will be responsible for creation and/or review of various documents such as annual reports for our Renal products, risk management plans, and changes to documents related to manufacturing and design changes. This person will work with cross functional teams globally; including individuals within Clinical, Medical, Quality, Regulatory, Commercial and Patient Safety departments.
Essential Duties and Responsibilities:
1. Provide literature search and analysis of results based on search criteria provided.
2. Position of clinical therapy “expert” either directly or through soliciting input from other resources internal or external.
3. Utilize analytical and problem-solving skills to assess issues, identify corrective actions and monitor effectiveness.
4. Responsible for the coordination, preparation and/or completion of clinical sections of renal therapy-related risk file updates, Core Company Safety Information (CCSI) or label updates, and other documents as assigned.
5. Develop and review quality related documents as they pertain to renal products.
6. Provide guidance and answers to clinical/medical questions from internal teams regarding renal products and therapies
7. Provide clinical support of complaint and adverse event analyses.
8. Assist Regulatory Affairs department by providing clinical input into the evaluation and response of Ministry of Health (MOH) queries.
9. Interface with other functional groups such as Medical Affairs, Regulatory Affairs, Quality, and global business units, as needed. Possess strong communication and interpersonal skills.
10. Work with team to define project deadlines and monitor project progress to ensure that documents required to support regulatory filings are submitted on time to regulatory authorities.
1. Strong clinical background in renal replacement therapies, Peritoneal Dialysis a must. Hemodialysis and Acute Renal Replacement Therapies a nice to have, but not required.
2. Capable of handling (assimilating) in-depth technical literature information from a variety of disciplines in order to be effective in this position.
3. Demonstrated analytical, problem solving skills.
4. Strong interpersonal skills and a demonstrated ability to manage conflict situations. Ability to maintain effectiveness under changing circumstances and priorities.
5. Excellent verbal and written communication and organizational skills required. Able to thoroughly document assessments and recommendations. Can move easily between meticulous attention to detail and the “big picture”.
6. Track record of delivering on commitments.
7. Experience in renal replacement therapies. Clinical research experience a plus.
Education and/or Experience:
1. Registered Nurse preferably with a bachelor’’s degree in Nursing.
2. Active Registered Nursing License in state residing.
3. Ability to travel to Deerfield office preferred.
4. A minimum of three year’’s recent clinical experience in training and managing home CAPD and APD patients.
5. Experience working with recent a Medical Device Company is preferred (permanent or contracting positions).
6. Medical APD device software product knowledge/clinical experience required
7. APD device knowledge/clinical experience required.
8. Expertise in scientific and/or medical writing preferred.
9. Exposure to working with the FDA and/or other regulatory authorities preferred.
Interview Platform: Phone followed by onsite for local candidates/ phone followed by Video WebEx for non-local candidates
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)