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Regulatory Affairs Associate II
The Disclosures & Transparency function resides organizationally within Regulatory Documentation and Submissions (RDS) organization at Gilead and is responsible for Clinical Trial Disclosure and Data Transparency activities. These activities include the registration of, and results posting for Gilead sponsored clinical trials on appropriate Clinical Trial Registries, the generation and facilitation of clinical 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.
This position reports directly to the Associate Director of Disclosure and Transparency. The Sr. Associate of Disclosure and Transparency plays an important role in key D&T activities and participates in department strategy and process improvement for defined initiatives. This experienced professional will support the team to ensure comprehensive, high quality and compliant clinical trial registration and results submission of applicable Gilead sponsored clinical trials on the Federal Drug Administration (FDA) Clinical Trials Registry (www.clinicaltrials.gov ) and/or centralised European Union clinical trial registries including EU-CTR, and ENCePP (EU-CTR: www.clinicaltrialsregister.eu; ENCePP: http://www.encepp.eu/encepp/studiesDatabase.jsp). This position may also support data transparency activities such as the preparation of Policy/0070 packages for submission to the European Medicines Agency (EMA).
- Partners with and leads interactions with other functional areas and demonstrates an ability to effectively collaborate cross-functionally
- Manage registration of new protocols, maintenance of protocol records, and results postings
- Participates in redaction of clinical trial documents for EMA Policy 0070 and generation of redaction justification tables
- Support strategic Disclosure & 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 disclosure activities
- Demonstrates exceptional operational and organizational skills to ensure disclosure 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 Gilead compliance
- Participates in group initiatives and authoring of training manuals, checklist documents, business practices, or standard operating procedures (SOPs)
- 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:
- Manage clinical trial disclosure activities and participates in and/or authors new protocol registrations/registration updates and results postings for release on the ClinicalTrials.gov, centralised European clinical trial registries including EU-CTR, and ENCePP.
- Participates in redaction of clinical trial documents and generation of redaction justification tables required for Policy/0070.
- Works with others in D&T to drive development and implementation of processes, standards, and training material for Disclosure & Transparency activities.
- Works effectively within an evolving and dynamic environment and has a proven track record to quickly adapt to changing regulations, processes, priorities, and deadlines.
- Proven ability to anticipate and identify areas of change, assess potential impact, propose strategic adaptability, and lead and oversee change management efforts.
- Drives intra and inter departmental process optimization to improve quality, efficiency, and productivity.
- Have excellent verbal and written communication skills and interpersonal skills. Shows flexibility in communication style to work effectively in a team environment.
- Has well-developed computer skills including proficiency in MS Office, Adobe, SharePoint, and Regulatory Document Management Systems (e.g. Documentum).
- Ability to build productive working relationships internally and externally.
- A BS degree
- Typically 6+ years of relevant clinical development or regulatory affairs experience in the pharmaceutical/biotechnology development environment (e.g. Sponsor or Clinical Research Organization (CRO))
- Preferably 3 or more years of direct experience in disclosure 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.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
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Job posted: 2022-01-03