Senior Associate, Global Clinical Trial Transparency Permanent Position

Senior Associate Global Clinical Trial Transparency - Permanent Position (4131)

The Company

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology Neurology and Pain therapy areas.

By joining Eisai you will be working for an organisation with a human healthcare philosophy which means that we put the patient first in everything we do.

Your new role

The Senior Associate Disclosure Global Clinical Trial Transparency (GCTT) will perform all aspects of clinical trials registration and results posting on EudraCT and similar databases worldwide (disclosure operations process) as directed. To ensure compliance with the processes which support Eisais Policy for Clinical Trial Transparency and applicable regulations. Demonstrate success in working collaboratively independently as required with internal and external team members to ensure Eisais Global Clinical Trial Transparency responsibilities are achieved.

Will include but will not be limited to the following activities:

• Performing/coordinating all activities for the registration and results posting to EudraCT and similar databases worldwide in compliance with policy and procedures and applicable regulations.
• Working closely with the internal Eisai team and vendor to ensure they understand their roles and responsibilities related to Eisais disclosure obligations
• Working with the internal Eisai team to ensure the source information is provided for disclosure activities in a timely manner
• Working closely with the vendor to ensure that the studies are registered and results are posted to major registries in compliance with policy procedures and applicable regulations.
• Disclosure Tracking Database: ensure Eisais disclosure information are maintained and in compliance with relevant procedures
• Process and Training: maintain Eisai process documents and training materials in line with regulation updates and acquired knowledge.
• Maintain awareness of existing and emerging guidance on public disclosure processes requirements and information including EMA FDA and international regulatory requirements for transparency registration results posting content and format.
• Supporting other clinical transparency activities within GCTT as required

What are we looking for

• Education to . 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 least one of the following areas;
  
  • Clinical trial transparency
  • Clinical trial disclosure
  • Medical Writing
• Experience of supporting and managing tasks / projects by establishing strong relationships and coordinating those resources (internal and external) 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 in return

Eisai offers a competitive salary and excellent wider benefits package that includes

• Hybrid working - 2-3 days onsite
• 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

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility which is our EU Headquarters and offers an inclusive and collaborative working environment.

What you need to do next

If you are interested in this position please click apply now at the top of this advert. Upon submitting your application you will be asked to complete your profile and upload a copy of your CV along with any additional information to support your application.
If you have any questions please contact us on

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.

Eisai EMEA EDI Commitment Statement

We believe that diverse and inclusive teams promote wellbeing learning and innovation helping Eisai serve our patients their families our employees and society.
Our commitment is:

• to embrace and celebrate our differences respecting and valuing each other.
• to include equity diversity and inclusion practices in all that we do so everyone has a full sense of belonging.
• to value individual talent where every employee can be themselves and thrive in an environment of openness trust and integrity