11 days old

Principal Medical Writer

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

A Principal Writer in the Global Regulatory Medical Writing and Submission Management organization at Teva provides basic-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.  This role supports the ares of drug development, product registrations, and product marketing.  Travel Requirements:  Minimal International and domestic

 

Essential Duties & Responsibilities:


Oversees/Mentors for all document types
Offers leadership and basic accountability, strategic assistance, and planning support at the product level for clinical regulatory documents
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 know-how to medical writers preparing any document type
Aids medical writing (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
Performs quality assurance review of documents
Participates in meetings at the document team and clinical subteam levels
Participates in 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 and iIdentifies, deploys and manages resources
Exhibits competent 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

 

Qualifications

Required:

PhD in life sciences (or other related field) with a minimum of 3 years of experience related to medical writing, or

Masters in life sciences (or other related field) with a minimum of 6 years of experience in medical writing related activities. Mastery of Microsoft (MS) Word and excellent English, both written and spoken.

Considered a capable resource with 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 level
Works successfully with an intermittent level of direct supervision and has knowledge of global regulations and guidelines for document submissions

Function
Research & Development
Sub Function
Clinical Development
Reports To
In process of validation
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: 2020-03-16 Expires: 2020-04-15

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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Principal Medical Writer

Teva Pharmaceuticals
West Chester, PA 19380

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