Teva Associate Director Transparency Disclosure 

United States, Pennsylvania, East Bradford Township 

122707386

The Associate Director of Transparency and Disclosure (T&D) is responsible for leading and managing global Transparency & Disclosure activities. This role will serve as a subject matter expert and will manage the processes and procedures to ensure compliance with global regulatory requirements. The Associate Director will partner with and lead interactions with senior management in relevant functional areas and manage staff who are directly involved in activities related to disclosure and transparency. Oversight of staff who manage clinical trial registry activities, lay language results summaries, and data sharing requests will also be in scope.

• Ensures compliance with US/EU requirements for clinical data transparency and disclosure, including EMA Policy 0070, EMA Policy 0043 and Health Canada.
• Ensure development of plain language results summaries.
• Manages and oversees vendor/CRO involvement for registrations, results postings, and plain language summaries to assure data harmonization.
• Oversees facilitation of registration and results postings in Teva’s clinical trial disclosure platform for global data harmonization management.
• Oversee internal systems experts, including but not limited to disclosure and document management databases.
• Assures quality and accuracy with clinical trial information in public registries.
• Facilitates review and assessment of data sharing requests from external researchers.
• Ensures maintenance of transparency, including routine updates of active registrations and updates to results disclosures.
• Establishes and maintains close working relationships with project teams, as well as with other internal stakeholders.
• Works cross-functionally to continuously improve processes and facilitates SOP updates.
• Internal advocate for Teva’s disclosure standards, policy, and public accessibility to data.

• PhD/PharmD with a minimum 6 years experience or a Master’s with a mnimum of 8 years experience
• Advanced degree in Life Sciences, Pharmacy, or Medicine.
• A minimum of 6 years of experience in Transparency and Disclosure

Experience Preferred:

• 6-8 years of experience in Transparency and Disclosure preferred.
• A broad understanding of the legal/regulatory requirements and guidelines with regard to clinical trial transparency and disclosure.
• Working knowledge of clinicaltrials.gov, clinicaltrialsregister.eu/CTIS databases, Policy 0070
• An understanding of the clinical drug development process, including clinical trial design, operations, and results analysis. Relevant experience in Regulatory Affairs.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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.