Global CTA Submission Manager - Remote

Recruiter
CK Group
Location
Kent
Salary
£41.00 per hour PAYE
Posted
09 Apr 2021
Closes
16 Apr 2021
Ref
50348
Contact
Julie Marshall
Contract Type
Contract
Hours
Full Time
CK Group are recruiting for a Global CTA Submission Manager to join a company in the Pharmaceutical industry on a contract basis for 12 months. This role is remote working.

Company:

Our client is one of the largest bio-pharmaceutical companies operating in the UK. They are committed to working with the NHS, academia and other healthcare organisations to improve the delivery of healthcare and achieve the best health outcomes for people in the UK.

Location:
This Global CTA Submission Manager role will be working remotely from home.

Salary:
£45.90 per hour Umbrella / £41.00 per hour PAYE.

Global CTA Submission Manager Role:
  • Drive global submission management activities for their assigned assets and partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.
  • Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
  • Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
  • Liaises with Study Management, regarding essential core documents that cross both HA and EC submission and translation processes.
  • Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

Your Background:
  • B.S./BSc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
  • In-depth understanding and proven execution of CTA processes globally.
  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
  • Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive.
  • Understanding of EU Clinical Trial Regulation, desirable.

Apply:
For more information or to apply for this Junior Drug Safety Associate position, please contact CK Group, quoting job ref 50348.

It is essential that applicants hold entitlement to work in the UK.

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