Regulatory Disclosures Manager

4 weeks ago

Welwyn Garden City, United Kingdom CK GROUP Full time

CK Group are recruiting for a Regulatory Disclosures Manager to join a pharmaceutical company with a site based in Welwyn on a contract basis for 12 months. This role has been deemed outside of IR35 so Ltd, Umbrella and PAYE options are all available.
**The Role**:
The main purpose of the role will be to:

- Be responsible for the accurate and timely posting of applicable clinical trial protocols, protocol amendments and study results onto the public registries (ClinicalTrials.gov (CT.Gov) and EudraCT).
- Identify and accurately assess clinical trial studies required for registry and results postings, including applicable clinical trials for results posting on CT.Gov.
- Liaise with clinical study teams and other applicable groups/stakeholders (e.g. biostatisticians, medical writers, clinical operations, clinical scientists) to ensure that they understand responsibilities, disclosure registry requirements, timelines anddeadlines and to ensure timely review and approval of documentation for registry and results records.
- Coordinate registry and results record creation with contract medical writing personnel, providing documentation, contacts and work prioritization when necessary; facilitate adjudication of comments between clinical study teams and medical writers.
- Track and monitor workflows for registry and results entries to ensure timely completion of activities; track correspondence via a shared global inbox and ensure applicable responses are provided in a timely manner.
- Operate applicable systems to complete the necessary uploads; trouble-shoot system issues with teams and technical support.
- Actively contribute to the development and maintenance of policies and/or Standard Operating Procedures on clinical trial registry and clinical trial results database processes.
- Actively contribute to Team Knowledge Sharing meetings and to company initiatives as required.

**Your Background**:
To succeed in this role, you will come from a Life Science background and previous regulatory disclosures experience. In addition you should have demonstrable experience of:

- ClinicalTrials.gov (CT.Gov) registration, maintenance and results posting activities and/or EudraCT results posting activities along with the use of disclosures management systems, e.g. PharmaCM.
- Well versed with the CT.Gov (FDA) and EudraCT (EMA) registry legal requirements and deadlines; familiarity with other public and local registries (e.g. EU PAS; ISRCTN) desired.
- Demonstrated pharmaceutical/biotechnology industry experience including experience in interacting with stakeholders globally along with working closely with Vendors/CROs.
- Graduate degree in Life Sciences or equivalent (Life Sciences disciplines preferred).
- Experience with medical writing or editing; familiarity with Protocol Documents and Clinical Study Reports.
- Understanding of the drug development process; understanding of the regulations, processes and systems related to clinical trial registries and disclosure, particularly CT.Gov.

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54713 in all correspondence.

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