Associate Director, Medical Writing - REMOTE

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 a significant level of oversight and expert 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. He or she should have experience leading regulatory global submissions.
 

The Associate Director offers clear leadership and extensive accountability, strategic vision, and planning direction at the therapeutic-area level (may multiple therapeutic areas) 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 proficiency to medical writers preparing any document type. He or she must have excellent written and oral communication skills.

Travel Requirements: International and domestic

Essential Duties & Responsibilities:

• Oversees/Mentors for all document types
• Provides leadership/strategy at the therapeutic area level
• Contributes substantively in meetings at the therapeutic area level
• Leads/Recommends the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
• Guides medical writing (and other) staff (including senior-level staff) on the organization and presentation of information within documents, as well as the design and format of data displays.
•  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
• Exhibits expert 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
• Responsible for tracking/proving metrics and established key performance indicators, contributing to the budget process, and handling invoices
• Identifies processes that require improvement, and demonstrates “big picture” perspective, leveraging experience, to recommend strategies and solutions
• Contributes to manuscript preparation as needed

Qualifications

Education Required:

• PhD or Masters degree in the life sciences (or other related field) with a minimum of 10 years of experience

Experience Required:

• A minimum of 10 years experience in the pharmaceutical industry with depth of knowledge related to the conduct of clinical trials and global submissions
• Considered a proficient manager with significant regulatory medical writing expertise.
• Considered an internal expert in all aspects of regulatory medical writing and clinical drug development
• An in depth understanding of the clinical drug development process, including clinical trial design, operations, and results analysis
• 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

Function

Sub Function

Reports To

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