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Sr Dir Clinical Development Medical Writing

Date: Mar 25, 2021

Location: Netanya, IL, 11111

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!

Position Summary

A Senior Director in Global Regulatory Medical Writing & Data Transparency and Disclosure provides leadership, direction, and competence to a team of medical writers/managers and electronic document specialists within Clinical Specialty Development for the production of high-quality clinical research documentation, which adheres to departmental standards and regulatory guidelines, in support of drug development, product registrations, and product marketing to meet the company’s global strategic, scientific, regulatory, and commercial goals. The Senior Director offers clear leadership and extensive accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents. He or she serves as a liaison among internal/global functional groups to ensure optimal use of resources in making medical writing support available for all projects. The Senior Director provides mentoring and proficiency to manager-level direct reports.
The primary responsibility of the Senior Director, Global Head of Regulatory Medical Writing & Data Transparency and
Disclosure, is to lead, mentor, educate and direct all global regulatory medical writing and transparency aspects within the R&D division.  Included within this scope of responsibility is planning and execution of robust outsourcing, resourcing, risk management and technology strategies that ensure the timely and high quality delivery of clinical documents and submission deliverables.
Travel Requirements:  International (specifically to Israel) and domestic
 

Essential Duties & Responsibilities

  • Expert in all document types
  • Provides leadership/strategy at the global medical-writing and data transparency and disclosure function level
  • Builds and maintains relationships and interfaces globally with Clinical Specialty Development and other departments to provide medical writing and electronic document management/publishing support for worldwide research, development, and registration of Teva products 
  • Provides resource, identifies and manages areas of resourcing conflicts in the management of multiple programs
  • Contributes/Recommends substantively in meetings at global medical-writing function and management/executive levels; represents Global Regulatory Medical Writing on departmental and other committees to ensure that regulatory guidelines and document preparation needs and time lines are considered during the planning process 
  • Provides guidance and direction for preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents.
  • Explore, evaluate and recommend new technologies and procedures that would contribute to more efficient document preparation and improved document quality
  • Provides guidance and direction in Clinical Research Organization (CRO) alliance and other outsourcing activities
  • Analyzes resource needs strategically at the global medical-writing function level
  • Accountable for quality assurance of documents at the global medical-writing function level
  • Exhibits expert/mentor collaboration, conflict-resolution, and influencing skills
  • Leads the recruiting/hiring process, and professional development and retention of manager-level direct reports including identifying learning/training opportunities and executing development plans; maintains professional knowledge by affiliating with professional organizations, attending conferences and seminars, and reading applicable literature
  • Responsible for tracking/proving metrics and established key performance indicators, and leading the budget and invoicing processes at the global medical-writing function level •  
  • Directs/Guides in manuscript preparation as needed by manager-level staff

Qualifications

  • PhD in life sciences (or other related field) with a minimum of 10 years of experience related to medical writing or Masters in life sciences (or other related field) with a minimum of 15 years of experience
  • Expert/Mentor at global function level to management-level staff
  • Highly skilled at setting regulatory medical writing processes/policies and technical and editorial standards
  • Considered an internal expert in all aspects of regulatory medical writing, T&D, and clinical drug development
  • Knowledge of global regulations and guidelines for T&D and document submissions
  • Excellent English, both written and spoken
  • Excellent organizational/planning and problem-solving skills at the global function level
  • Workssuccessfully with no direct supervision

Function

Research & Development

Sub Function

Clinical Development

Reports To

VP, Head of Global Biometrics

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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.