Senior Specialist, Transparency & Disclosure (Remote)

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Senior Specialist in Transparency & Disclosure provides project management oversight and expert guidance in the production of clinical research documentation in support of drug development, product registrations, and related requirements. The Senior Specialist offers clear leadership and accountability, and planning direction at the therapeutic-area level (may manage multiple therapeutic areas) for providing Transparency & Disclosure deliverables on time. Manages processes and procedures to assure compliance with global regulatory requirements and Teva policies for clinical data transparency and disclosure, and global harmonization and accuracies across global registries.

 

 

Travel Requirements:  minimal

 

Location: US-based Remote  (Eastern time zone preferred)  

 

RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS NOT AVAILABLE

How you’ll spend your day

• Lead procedures for compliance with US/EU requirements for clinical data transparency and disclosure, including EMA Policy 0070, EMA Policy 0043 and Health Canada.
• Manages vendor/CRO involvement for registrations, results postings, and plain language summaries to assure data harmonization.
• Provide oversight for facilitation of registration and results postings in Teva’s clinical trial disclosure platform for global data harmonization management.
• Monitor internal systems experts, including but not limited to disclosure and document management databases.
• Write and edit transparency & disclosure documents including registration & results disclosure forms with minimal oversight; Assures quality and accuracy with clinical trial information in public registries.
• Facilitate review and assessment of data sharing requests from external researchers.
• Assure maintenance of transparency, including routine updates of active registrations and updates to results disclosures.
• Work cross functionally to continuously improve processes
• Establish and maintain close working relationships with local and global project teams, as well as with other internal colleagues.
• Effectively communicate the purpose and requirements for redaction activities.
• Liaise with Legal and Corporate Alliance Management and other stakeholders to assure protections in the disclosure of clinical information.

Your experience and qualifications

Bachelor's degree from an accredited college or university + 4 years of relevant experience (e.g., regulatory, statistics, laboratory, clinical operations).

-OR-

Master's degree from an accredited college or university + 2 years of relevant experience (e.g., regulatory, statistics, laboratory, clinical operations).

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance

Reports To

Senior Director, Data Transparency & Disclosure

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.

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 st