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Eisai EMEA

Associate, Global Clinical Trial Transparency

Hatfield
Posted about 22 hours ago
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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 Associate, Disclosure, Global Clinical Trial Transparency will perform tasks in support of clinical trial disclosure activities 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:

  • Working collaboratively with internal team members to perform tasks in support of clinical trial disclosure on clinicaltrials.gov, EudraCT, and similar databases worldwide in compliance with policy and procedures, and applicable regulations.
  • Working with the internal Eisai team to ensure the source information is provided for disclosure activities in a timely manner.
  • As required, working closely with the vendor and internal Eisai team 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.
  • Maintain awareness of existing guidance on public disclosure processes, requirements, and information, specifically EMA, and FDA.
  • Supporting other clinical transparency activities within GCTT as required.

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What are we looking for?

  • Education to B.Sc. level or equivalent.
  • Experience of supporting tasks / projects, by establishing strong relationships (internal and external) to achieve deliverables in compliance with process.
  • Awareness of clinical development within the pharmaceutical industry.
  • Awareness of clinical disclosure rules such as FDAAA801, EudraCT.
  • 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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Skills

Clinical Trial Disclosure
Regulatory Compliance
Collaboration
Project Support
Clinical Development Awareness
Clinical Disclosure Rules
Software Proficiency
Database Management

Location

Hatfield, England, United Kingdom

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