Associate Director, Transparency and Disclosure
West Chester, United States, Pennsylvania, 19380
Who we are
The opportunity
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.
How you’ll spend your day
- 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.
Your experience and qualifications
- 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.
Enjoy a more rewarding choice
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.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
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.
Already Working @TEVA?
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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 status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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