Hobson Prior are in search for a Regulatory Disclosures Specialist to join a world leader within diagnostic solutions who have a strong product portfolio and an excellent pipeline of future products. This position will ensure that Regulatory Disclosures meets all the applicable regulatory requirements for posting study information onto ClinicalTrials.gov, EudraCT, and the EU PAS registry.

Job Responsibilities:

• Responsible for taking group meeting minutes.
• Data entry in support of the registration, maintenance, and results for ClinicalTrials.gov, EudraCT, and EU PAS registries.
• Partakes in site and/or regional PD Regulatory Disclosures departmental meetings.
• Stays up-to-date of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the organisation's therapeutic areas and product development projects.
• Obtains and applies in-depth knowledge of the organisation and regulatory guidelines, procedures and best practices.
• As needed, provides regulatory disclosures expertise to cross-functional teams and other groups.
• Contributes to development and maintenance of policies and/or Standard Operating Procedures on clinical trial registry and clinical trial results database processes.
• Recognises studies required for registry and results postings, including applicable trials for results postings on relevant external websites.
• Ensures that responsible PDR management and staff are aware of timelines, deadlines and other requirements.
• Tracks missing/late registry entries and Clinical Study Reports and liaises with PDR teams regarding dates of new product or line extension approvals.
• Works with cross-functional team members to obtain data, reviews and approvals required for completion of registry and results entries on internal and external websites.
• Monitors workflows for registry and results entries to ensure timely and on-target completion.
• Completes document and data uploads in applicable systems.
• Ensures protocol information is included in the registry as soon as the study design is finalized and first ethical/regulatory approval is received.

Key Skills:

• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat.

Requirements:

• Bachelor's degree preferred (life sciences disciplines strongly preferred).
• Medical writing and/or editing experience.
• You will have 3 or more years' relevant experience in the pharmaceutical/biotechnology industry. Some previous experience in regulatory affairs or other product development functions is preferred.
• Some understanding of international regulations, processes and issues in drug/biologics development is preferred.
• Some understanding of product and safety profiles.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.