Director, Regulatory Affairs

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Job Description

Director, Disclosures & Transparency

My client, a world class biopharmaceutical company now have a vacancy for a Director, Disclosures & Transparency.  A background in Regulatory Affairs is ideal for this role.


The Role:
The Disclosures & Transparency function resides organizationally within Regulatory Documentation and Submissions (RDS) organization and is responsible for Clinical Trial Disclosure and Data Transparency activities. These activities include the registration of, and results posting for sponsored clinical trials on appropriate Clinical Trial Registries, the generation and facilitation of trial/clinical product transparency activities and deliverables in accordance with relevant laws, regulations, and policies. In addition, D&T is responsible for managing the Individual Patient Data Sharing process with qualified external requestors.
Essential Functions:
Partners with and leads interactions with International Regulatory Affairs and demonstrates an ability to effectively collaborate cross-functionally
Oversees compliance and maintain oversight over all Disclosure and Transparency activities in Countries with mandatory D&T regulations outside the US
Oversees registration of new protocols, maintenance of protocol records, and results postings outside of the US
Oversees redaction of clinical trial documents for mandatory regulations
Serves as a subject matter expert, primary point of contact outside the US and corporate resource for the D&T group
Trains others on international regulatory and legal clinical trial disclosure and transparency requirements
Support strategic Disclosures & Transparency initiatives within the group and cross functionally
Support continuous improvement and ensures processes are efficient, scalable, and effective
Participates in companywide process improvements and development of initiatives
Acts as an advisor to various groups on appropriate strategies for disclosures activities
Demonstrates exceptional operational and organizational skills to ensure disclosures and transparency activities are performed on time and with the highest of standards
Evaluates evolving regulations and public guidance on clinical trial disclosure and data transparency to maintain Company compliance
Participates in group initiatives and authoring of training manuals, checklist documents, business practices, or standard operating procedures (SOPs)
Responsible for maintaining and oversight of routine metrics for reporting to Head of D&T
Supports and Consults with internal core team and/or sub-teams on strategic transparency initiatives.
Develops and maintains process and system to optimize efficiency, maximize content reuse and ensure quality.

Knowledge, Experience & Skills:
A BS degree
Knowledge of Global Clinical Trial Transparency and Data Sharing Requirement preferred.
A well-versed understanding of Regulatory requirements outside the US.
Typically, 10+ years of relevant clinical development or regulatory affairs experience in the pharmaceutical/biotechnology development environment (e.g. Sponsor or Clinical Research Organization (CRO))
Preferably 5 or more years of direct experience in disclosures and/or data transparency, clinical operations or medical writing/clinical submissions.
Core understanding and familiarity with Clinical Development, Clinical Trial conduct, and the Regulatory Submission process is preferred.

Essential:
Experience overseeing clinical trial disclosure activities and partners with International Regulatory Affairs or Affiliates or local CROs to ensure new protocol registrations/registration updates and results postings are released on mandatory clinical trial registries outside the US in a timely manner.
Has excellent verbal and written communication skills and interpersonal skills. Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management staff.


For full details and confidential discussion contact Tina at +353 1 2784671 or email tdunne@thornshaw.com

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Tina Dunne

Recruitment Manager 01 2784671 tdunne@thornshaw.com
  • Salary:Negotiable
  • Location:Dublin North
  • Type:Permanent
  • Category:Science,Thornshaw
  • Ref.no:JO-2003-448383_20