17 days old

Associate Director Medical Writing, Biometrics

West Chester, PA 19380
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

An Associate Director, in Global Regulatory Medical Writing, provides advanced-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 Associate Director offers leadership and high accountability, strategic management, and planning coordination at the therapeutic-area level for clinical regulatory documents, and 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. The Associate Director provides mentoring and competence to medical writers preparing any document type.

 

Essential Functions:

 
Oversees/Mentors for all document types
Acts as a/Mentors Submission Managers for Regulatory filings
Recommends to medical writing (and other) staff (including senior-level staff) proper organization and presentation of information within documents, as well as the design and format of data displays
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 contractor oversight
Analyzes resource needs and assignments strategically
Performs quality assurance review of documents
Participates in the recruiting/hiring process, and development of direct reports including identifying learning/training opportunities and executing development plans
Responsible for tracking/proving metrics and established key performance indicators, contributing to the budget process, and handling invoices

Qualifications

Requirements:
 
PhD in life sciences (or other related field) with a minimum of 7 years of experience related to medical writing or Masters in life sciences (or other related field) with a minimum of 8 years of experience
Excellent English, both written and spoken
Considered a competent manager with advanced regulatory medical writing expertise.
Considered an internal expert in all aspects of regulatory medical writing, Submissions and clinical drug development
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 therapeutic area level
Works successfully with no direct supervision

 

Function
Research & Development
Sub Function
Biometrics
Reports To
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.

Categories

Posted: 2020-03-10 Expires: 2020-04-17

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Director Medical Writing, Biometrics

Teva Pharmaceuticals
West Chester, PA 19380

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