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Senior Manager -Global Regualtory Medical Writer

Date: May 11, 2019

Location: Frazer, Pennsylvania, US, 19355

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

A Senior Manager, in Global Regulatory Medical Writing, provides intermediate-level oversight and guidance, as well as resource management for the direct medical-writing support given to Clinical Specialty Development (and other departments as appropriate) in the production of clinical research documentation in support of drug development, product registrations, and product marketing. The Senior Manager offers leadership and fundamental accountability, strategic supervision, and planning assistance at the product and program levels for clinical regulatory documents.

 

Essential Functions:

 

  • Oversees/Mentors for all document types
  • Ensures that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
  • Provides mentoring and capability to medical writers preparing any document type
  • Assists medical writing (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
  • Provides leadership/strategy at the product/program level
  • Participates significantly in meetings at the product/program level
  • Leads/Recommends the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
  • Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities
  • Provides oversight for contractors
  • Identifies, deploys and manages resources
  • Performs quality assurance review of documents
  • Exhibits proficient collaboration, conflict-resolution, and influencing skills.
  • Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans
  • Contributes to the budget process, and handling invoices

Qualifications

  • Bachelor’s in life sciences (or other related field)  with a minimum of 5 years of experience related to medical writing or Masters in life sciences (or other related field) with a minimum of 9 years of experience
  • Excellent English, both written and spoken
  • Considered a competent manager with advanced regulatory medical writing expertise.
  • Ability to organize and present information and to communicate regulatory medical writing processes and technical and editorial standards
  • Excellent organizational/planning and problem-solving skills at the product and program level
  • Works successfully with a low level of direct supervision

Function

Research & Development

Sub Function

Clinical Development

Reports To

In process of validation

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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