Regulatory Disclosures Manager

  • Salary: Competitive
  • REF Number: 00054285
  • Consultant: Emily Mills
  • Contact: 01246 457 710
  • Date Published: 16.08.2022
  • Closed Date: 14.03.2023
  • Industry: Pharmaceutical
  • Location: Welwyn Garden City, Home/Field Based, Home Counties
  • Functional Expertise: Regulatory Affairs

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 disclosuresmanagement 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 withmedical 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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