Regulatory Disclosures Manager

4 days ago

Welwyn Garden City, United Kingdom CK GROUP Full time

CK Group have a fantastic opportunity for a Regulatory Disclosures Manager to join a leading global pharmaceutical company based in Welwyn Garden City. This is a permanent role. **Regulatory Disclosures Manager Role**:
As a Regulatory Disclosures Manager you will:

- Post 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.
- 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.
- Coordinate registry and results record creation with contract medical writing personnel.
- Track and monitor workflows for registry and results entries to ensure timely completion of activities.
**Your Background**:
To be considered for this position you will have:

- Previous direct regulatory disclosures experience - required.
- Solid experience with 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.
- A 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.
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54285 in all correspondence.

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