Medical Affairs Stake Holder Manager

Who are we?

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 Sr. Manager, Business Application is responsible to maintain, integrate and implement software applications within R&D Medical Affairs area.  This includes acting as a liaison between the IT development and support groups, and business units for the development and implementation of new systems and enhancement of existing systems.   This role will also evaluate new IT developments and evolving business requirements, and recommend appropriate systems alternatives and/or enhancements to current existing computer systems.

Travel Requirements:   
     

Essential Duties & Responsibilities and Percentage of Time

1. Provide functional and technical support to Medical Affairsl users globally
2. Understand the business processes and partner with the business system owners to implement systems to support their requirements/business process for new systems or new requirements in existing IT systems including all aspects such as delivery timelines
3. Adhere to GxP Manufacturing and/or GxP Clinical Guidelines
4. Understand and Analyze business requirements as applicable in existing systems or current vendor/systems landscape for new systems
5. Coordinate software application testing, quality assurance, configuration, installation and support to ensure smooth, stable and timely implementation of new software and updates to installed applications
6. Reviews system requirements and business processes; codes, tests, debugs and implements software solutions. 
7. Addresses issues with impact beyond own team based on knowledge of related disciplines
8. Analyze Business Requirements and create clear & concise Functional Specifications according to standards for technical staff to use in Detailed Design and software development
9. Preparation of related materials such as training materials and client User Acceptance Test materials, release notes, etc
10.      
 

Qualifications

Education Required:    Bachelor’s degree in Computer Sciences/Engineering, associated discipline or the equivalent experience 
Education Preferred    Bachelor’s degree in Computer Sciences/Engineering
Experience Required:    5-10 years of Pharmaceutical IT Systems experience
Working knowledge of FDA compliance, specifically in 21CFR Part 11 regulations and GAMP guidelines
Strong interpersonal and communication skills
Ability to work independently

Experience Preferred:    Wroking  knowledge of Medical Affairs systems 

Specialized or Technical Knowledge Licenses, Certifications needed:     Understanding of GMP’s, Part 11 Requirements,  

Functional Knowledge:    Experience with project management, good presentation skills, leadership in a formal team environment, previous pharmaceutical experience 

Company/Industry Related Knowledge:    Working  knowledge of Medical Affairs System processes

Job-specific Competencies

1.        Expert knowledge of Project management tools e.g. MS Project

2.        Strong knowledge of end-to-end development of software applications from requirement analysis to system designing, coding, testing, de-bugging, documentation and implementation

3.        Ability to manage multiple tasks with changing priorities required.

4.        Strong technical skills
 

Function

Sub Function

Reports To

Dir IT Business Application, IT Medical Affairs 

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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.