KendallWestRecruiter Since 2001
the smart solution for Kendall West jobs

Clinical Research Studies - Clinical Regulatory Affairs Associate

Company: TEVA PHARMACEUTICALS USA
Location: Miramar
Posted on: August 24, 2019

Job Description:

Company Info Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth! Job Description The Regulatory Affairs Specialist is responsible for establishing, maintaining, and providing administrative management of the Regulatory Documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs). Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times Generates, facilitates and maintains all study related regulatory documents from prestudy through study close out, ensuring quality, accuracy, and timeliness Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements Prepares and maintains records for archiving and/or retrieval Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits. Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issues Provides administrative and operational support to internal departments and clinical management teams Qualifications Education: a Bachelor's Degree in a health field is required. Experience organizing documents, Trial Master File preferred, in a health environment. Minimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure CCRC preferred Possesses an understanding of medical terminology and the application of scientific/medical and clinical concepts to conduct clinical trials Possesses an understanding of the CFR and ICH Guidelines as they pertain to required study documents Possesses strong organizational and time management skills Excellent interpersonal, organizational, and time-management skills Able to work under extremely tight deadlines Strong analytical and decision making skills Able to coordinate workloads to meet extremely tight deadlines Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint), knowledge of MS Project, database and project management software desired Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 25 pounds. Function Regulatory Affairs Sub Function Medical Regulatory Affairs Reports To Manager, Regulatory Affairs Already Working @TEVA? The descriptors are broad global definitions based on Towers Watson grade and career path language. The descriptors are not specific position descriptions and are intended to be used for reference purposes only. If you have comments or suggestions for improvements we would very much like to hear from you! Please contact us at **********************************************. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. Nearest Major Market: Fort Lauderdale Nearest Secondary Market: Miami

Keywords: TEVA PHARMACEUTICALS USA, Kendall West , Clinical Research Studies - Clinical Regulatory Affairs Associate, Healthcare , Miramar, Florida

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


OBGYN Opening in the Palm Beach Area (Physician #)
Description: Large OBGYN practice with four locations expanding to Atlantis, FL. This practice provides a full range of obstetrics and gynecology for the Palm Beach
Company: Keith A. Long LLC, dba. Source Medical
Location: Palm Beach
Posted on: 09/19/2019

Remote Surgical Coder
Description: Remote Surgical Coder Abstracts clinical information from a variety of medical records and assigns appropriate ICD 10 CM and/or CPT codes to patient records according to established procedures. Analyzes, (more...)
Company: Mommy Jobs
Location: North Palm Beach
Posted on: 09/19/2019

Orthopedic/Total Joints Opportunity in Metro Miami, FL!! (Physician #1
Description: Orthopedics opening in Miami,
Company: DOCTORS CHOICE PLACEMENT SERVICES, INC.
Location: Miami
Posted on: 09/19/2019


Travel RN - IR
Description: Quest has been
Company: Quest Staffing
Location: Boynton Beach
Posted on: 09/19/2019

Health Insurance Agent - Work when & where you want, free inbound lead
Description: Licensed Health Insurance Agent - Total work freedom Join the revolutionary ASSURANCE platform in time to have the best OEP of your career. Earn from the industry's best comp plan, selling trusted health (more...)
Company: Assurance
Location: Boynton Beach
Posted on: 09/19/2019

Travel Nurse - L/D RN - Nampa, ID
Description: Travel Labor and Delivery Registered Nurse RN Start your next travel opportunity with this great Registered Nurse RN position in Nampa, ID Job Details ul li 1354/week take home pay li 7:00pm (more...)
Company: General Healthcare Resources - Travel Nursing
Location: Miami
Posted on: 09/19/2019

Medical Transcriptionist
Description: MT Desk is seeking a multi-specialty medical transcriptionist to work PT or FT remotely for a hospital setting. Experience 1 year or recent
Company: Mommy Jobs Online
Location: Homestead
Posted on: 09/19/2019

Outpatient Physician (Physician #)
Description: Well established primary care group in South Florida continues to experience growth. The
Company: myMDcareers
Location: Boynton Beach
Posted on: 09/19/2019

SEEKING BC/BE INTERNAL MEDICINE PHYSICIAN FOR BOCA RATON! (Physician #
Description: Join this traditional, well-established, single-specialty group of 3 Internal Medicine physicians seeking to hire a 4th due to expansion. Beautiful, well-equiped offices, with Lab
Company: National Health Partners
Location: Boca Raton
Posted on: 09/19/2019

Cardiac Cath Lab Technician
Description: Cath Lab Technicians AART, RCIS Locum Tenens Travel Assignments br The HCEN Client Staffing Agencies have made it a special request forNationwide opportunities br Looking for that perfect Cath (more...)
Company: HealthCare Traveler Jobs
Location: Miramar
Posted on: 09/19/2019

Log In or Create An Account

Get the latest Florida jobs by following @recnetFL on Twitter!

Kendall West RSS job feeds