This job posting may have expired!
Use our `search` to find similar offers.
Similar jobs

Sr. RA Consultant

Parexel International Corporation

Taipei, Taiwa

*This role has the responsibility as Global/Regional CTA Submission (Associate) Manager

Job Description:

• Drives global submission management strategy and activities for assigned protocols.

• Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA (Clinical Trials Application) submission development including authoring of Annex I and completion of relative associated documentation as required

• Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities

• Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.

• Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes

• Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

• Responsible for the co-ordination of translations for core documents required for submission

• Manages the compilation for core package build, contributing to CTA and authoring documentation as required

• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

• Discussed with relevant SMEs the interpretation of dossier requirements

QualificationsJob Qualification:

• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.

• In-depth understanding and proven execution of CTA and Central Ethics processes globally

• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards

Job posted: 2021-10-26

3