Compliance

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points,
• May participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• May support the clinical team performing Pre-Study Site Visits.

Regulatory and Site Start Up Specialist

• Assist in managing Dolby’s licensing compliance program in Taiwan
• Licensee audit processes and ensuring internal strategy alignments with other functional groups
• Accountable for Compliance revenue target and team performance in the mainland China region
• Develop and maintain a strong strategic partnership with the Dolby’s Commercial Partnership and Patent team
• Recover revenue from licensees identified as non-compliant in the use of Dolby IP
• Provide appropriate guidance and lead audit firms in obtaining accurate audit results
• Play an important role in the settlement negotiations
• Align with Dolby overall strategy and goals
• Lead and provide guidance to grow engagement managers in China
• Maintain necessary relationships with licensees and industry bodies

Compliance jobs in Taiwan

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Regulatory and Site Start Up Specialist

License Compliance Manager