Medical Writing

Description

• 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.
• 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.

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.
• Business-level proficiency in both English and Japanese
• Pharmaceutical professional background.
• 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.