Eisai
Senior Associate, Global Clinical Trial Transparency - Permanent Position
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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 clinicaltrials.gov, EudraCT, and similar databases worldwide (disclosure operations process) as directed. To ensure compliance with the processes which support Eisai’s Policy for Clinical Trial Transparency and applicable regulations. Demonstrate success in working collaboratively, independently as required, with internal and external team members to ensure Eisai’s 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 clinicaltrials.gov, 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 Eisai’s 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 Eisai’s 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.
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What Are We Looking For?
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Education to B.Sc. level or equivalent.
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Good knowledge of clinical disclosure rules such as FDAAA801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
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Demonstrated experience in the pharmaceutical industry, with exposure to least one of the following areas;
- Clinical trial transparency
- Clinical trial disclosure
- Medical Writing
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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.
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Understanding of clinical development within the pharmaceutical industry.
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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
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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 TalentAcquisition@eisai.net
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.
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