Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
* Oversee and execute the clinical trial disclosure process for assigned studies conducted by Astellas globally, including registration, updates and/or results disclosure.
* Provide training, share expertise and demonstrate proficiency in clinical trial disclosure activities.
* Contribute toward the establishment and refinement clinical trial disclosure processes while ensuring adherence to all applicable laws, regulations, industry guidance and corporate position.
* Monitor global regulatory requirements and the industry environment affecting clinical trial disclosure and communicate changes to the Clinical Transparency team.
Essential Job Responsibilities:
* Assesses requirements for clinical trial registration or disclosure of results.
* Prioritizes, oversees and performs the day-to-day operations of clinical trial disclosure, ensuring the timely completion, review and approval of registration and results disclosure activities for studies conducted globally.
* Makes appropriate decisions regarding the applicability and timing of clinical trial disclosure activities according to national laws, regulations, industry guidance and corporate position.
* Manages the review and approval process for clinical trial registrations and results disclosures, including communication with partner companies or collaborators.
* Facilitates periodic review of active registrations to ensure records are updated or verified as required.
* Uses independent judgment to assess clinical trial disclosure prioritization and appropriate problem solving to determine escalation of issues to management.
* Coordinates and oversees the work of consultants and vendors.
* Addresses inquiries related to clinical trial disclosure activities.
* Interacts and collaborates across various departments and management levels within Astellas to ensure open and effective communication.
* Provides feedback to clinical transparency leadership resulting from new and updated transparency requirements. Ensures compliance with evolving clinical trial disclosure requirements, including retrospective review and work as necessary.
* Develops and provides training to clinical transparency team members.
* Educates study team members and other organizational contacts on clinical trial disclosure policies and processes.
* contributes toward the continuous improvement of global clinical trial disclosure processes, procedures and standards.
* Establishes and maintains global working relationships.
* This position has a direct impact on ensuring compliance with clinical trial disclosure laws, industry guidance and corporate policy. Lack of compliance with disclosure laws and guidance could result in significant regulatory fines, negative press or other public consequences for the company.
* Responsible for the timely completion of several hundred clinical trial disclosure deliverables across the entire organization on an annual basis.
Reports to the Associate Director, Clinical Transparency or above. This position has no direct reports but may provide direction to Clinical Transparency Specialists, Associates, contractors and consultants. This position regularly interfaces with the study team and senior management, as well as key contacts from partner companies or collaborators.
* Bachelor's degree, or equivalent experience required.
* 5 years pharmaceutical industry experience required.
* Excellent organizational skills and high attention to detail.
* Self-directed and motivated, with ability to work without significant direct supervision, asking questions when necessary.
* Ability to manage multiple tasks and readily switch activities to accommodate priority needs.
* Proficient computer skills, including experience with MSWord and Excel.
* Healthcare professional background preferred.
* Clinical trials experience including study management, statistics, medical writing and / or data management preferred.
* Working knowledge of clinical drug development and clinical trial protocols preferred.
* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
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