About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com (https://www.astellas.com/en) .
Are you driven to make a real difference in the lives of patients
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose And Scope
- Execute the clinical transparency (i.e., registration, updates and/or results disclosure) or public disclosure processes for assigned studies and/or assets conducted by Astellas globally.
- Create documents (i.e., plain language documents, redacted documents, public disclosure plan) necessary to support clinical transparency and public disclosure.
- Demonstrate proficiency in clinical transparency or public disclosure activities.
- Contribute toward the establishment and refinement clinical transparency or public 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 transparency or public disclosure and communicate changes to fellow team members.
Responsibilities And Accountabilities
- Prioritizes, and performs the day-to-day operations of Clinical Transparency or Public Disclosure, ensuring the timely completion, review and approval of registration, updates and results disclosure activities or public disclosure strategy plans and public disclosure tracking mechanisms for studies and assets conducted globally.
- Makes appropriate decisions regarding the applicability and timing of clinical transparency or public disclosure activities according to national laws, regulations, industry guidance and corporate position.
- Manages the review and approval process for Clinical Transparency (clinical trial registrations, updates and results disclosures) and related documents (plain language and redacted documents) or public disclosure strategy plans and public disclosure tracking mechanisms, including communication with partner companies or collaborators.
- Facilitates periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required.
- Uses independent judgment to assess clinical transparency or public disclosure activities prioritization and appropriate problem solving to determine escalation of issues to management.
- Addresses inquiries related to clinical transparency and related documents or public disclosure activities.
- Interacts and collaborates across various departments and management levels within Astellas to ensure open and effective communication.
- Provides feedback to clinical transparency or public disclosure leadership resulting from new and updated transparency requirements. Ensures compliance with evolving clinical transparency or public disclosure requirements, including retrospective review and work as necessary.
- Contributes toward the continuous improvement of global clinical transparency or public disclosure processes, procedures, and standards.
- Establishes and maintains global working relationships.
Required Qualifications
- Bachelor's Degree, or equivalent experience required.
- Proficient 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.
Preferred Qualifications
- 3 years pharmaceutical industry experience in writing content for Clinical Transparency purposes.
- 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.
Working Environment
At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas Responsible Flexibility
What awaits you at Astellas
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Values: Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as One Astellas, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.
Category Quantitative Sciences & Evidence Generation (SUB00000148)
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
