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Senior Disclosure Specialist
2 months ago
About the Role
We are seeking a highly skilled and experienced professional to join our team as a Senior Associate/Manager, Disclosure, Global Clinical Trial Transparency. As a key member of our Global Clinical Trial Transparency team, you will play a critical role in supporting our disclosure operations and ensuring compliance with regulatory requirements.
Key Responsibilities
- Support the development and implementation of disclosure strategies and processes to ensure compliance with regulatory requirements.
- Collaborate with internal stakeholders to ensure timely and accurate disclosure of clinical trial information.
- Develop and maintain relationships with external partners and vendors to support disclosure operations.
- Provide training and support to team members on disclosure processes and procedures.
- Contribute to the development of policies and procedures to ensure compliance with regulatory requirements.
Requirements
- Education to B.Sc. level or equivalent.
- Good knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
- Demonstrated experience in the pharmaceutical industry, with exposure to clinical trial transparency, clinical trial disclosure, or medical writing.
- Experience of supporting and managing tasks/projects, establishing strong relationships, and coordinating resources to achieve deliverables in compliance with process and/or contract.
- Understanding of clinical development within the pharmaceutical industry.
- Experience of working with different software packages and platforms.
What We Offer
- Competitive salary and excellent benefits package.
- Hybrid working arrangement.
- Car/Car Allowance (depending on role).
- Electric charging points for Electric/Hybrid vehicles.
- Discretionary Bonus.
- Free onsite parking.
- Subsidised onsite restaurant and coffee shop.
- Learning and development opportunities.
- Retail discounts.
- Well-being & mental health awareness programmes.
- Multi-faith prayer room.
About Eisai EMEA
Eisai EMEA is a leading research-based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology, and Pain therapy areas. We are committed to putting the patient first in everything we do and offer a collaborative and inclusive working environment.
