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Mgr Medical Information Operational Excellence

Date: Jun 9, 2021

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

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 primary responsibilities are to provide assistance to management with the implementation of policies, processes and work instructions used for the intake and handling of medical information (MI) inquiries and processing of adverse events and product quality complaints; ongoing maintenance of products, templates, documents and FAQs within the LifeSphere MI (LSMI) database; weekly assignment of LSMI inquiries routed for QC review supports Teva US Specialty and Generic medicines to assure compliance with Teva policies, procedures, and departmental processes; Administration and management of the non-promotional review workflow process for documents routed through Veeva Global Medical Review (GMR) vault; development of strategies for retention, exchange, or acquisition of database products in accordance with management and departmental goals and objectives; and oversight of operations related to organizational growth, enhancement of procedures and work instructions, training, and development of strategies to optimize and enhance work flow, compliance with regulatory guidelines and corporate policies and procedures in accordance with management and departmental goals and objectives. Travel Requirements:  Limited Domestic and International, Approximately 10%

 

  • Assist management with day-to-day operational activities forTeva’ global MI database LSMI in support of US Generics and Specialty Medicines.  
  • Responsibility includes collaboration with Teva IT and vendor’s LSMI Administrator for the following:
  • System administration and maintenance
  • MI Content maintenance and integrity (entry of new products or NDCs into LSMI, standard response letters, FAQs, templates, supporting documents)
  • Report preparation (weekly, monthly, quarterly and ad hoc)
  • Validation activities in the event of system upgrades
  • Drafting and execution of the validation / User Acceptance Scripts that were executed in Teva’s Quality Validation System for GXP systems
  • Assist with projects/processes related to the submission of medical information inquiries via phone, email, internal field- based tools (ie, Veeva CRM) and other formats whereby MI requests are sent to Medical Information for triaging and processing
  • Assist with projects/processes related to dissemination of medical information responses to internal and external customers (consumers, HCPs, partners, affiliates, etc.)
  • Assist management with communications and collaboration with internal groups (CustomerService, Drug Safety/PhV, Quality Assurance Services, Compliance, Clinical Operations, Sales Operations, Teva R&D IT, etc.), GMA colleagues from EU and IM, and external partners/vendors (eg, Aris Global) to optimize business processes related to medical information inquiries as well as initial intake of safety-related reports and product complaints as applicable
  • Assist with the review and development of standard operating procedures and work instructions to support departmental processes

Qualifications

  • Bachelor of Science, Masters in Science degree, Bachelor of Pharmaceutical Science or Doctorate in Pharmacy.
  • Minimum two years of experience in medical information or related area involving data base systems
  • Displays proficiency with a range of computer applications, particularly MS Office Suite; familiarity with navigating the internet and use of search engines 
  • Familiarity with database management programs 
  • Experience with validation of GXP systems; Veeva Vaultand/or other document management systems
  • Attention to detail and documentation  
  • Scientific expertise in assigned therapeutic area(s)
  • Keen understanding of the pharmaceutical marketplace and industry as it pertains to medical information-related activities, FDA Code of Regulations
  • Experience in pharmaceutical industry or medical/research setting is preferred

Function

Medical Affairs

Sub Function

Medical Communications/Liaison

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. 


Nearest Major Market: New York City
Nearest Secondary Market: Newark