Clinical Trial Strategy Submissions Specialist
Clinical Trial Strategy Submissions Specialist
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Job Description
The Clinical Trial Strategy and Submissions Specialist is responsible for providing global regulatory expertise for Clinical Trials. This role acts as the primary liaison between global functions and affiliates to deliver clinical development regulatory strategies operations and outcomes. Additionally the Clinical Trial Strategy and Submissions Specialist is responsible for providing operational support as required to the CTS managers / senior managers.
Major Responsibilities
- Operational support to CTS Leads for submission preparation and processing of initial CTA applications amendments end of trial notifications etc.
- Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments end of trial notifications etc.
- Review of and input into documents related to clinical trial submissions managed by other stakeholders such as IB and Protocols.
- Monthly review and initial assessment of comparators SmPCs which are used in all AbbVie trials.
- Provide advice on submission strategy country requirements etc. as well as operational support for Regulatory submission preparation and processing of amendments.
- Follow company CTA processes.
- Populate relevant databases activity trackers and questions database within agreed timelines and compliance/reporting requirements and provide operational support for Regulatory and/or nonRegulatory systems that are critical for CTA submission and maintenance activities.
- Provide technical support on document preparation e.g. Excel spreadsheets Power point presentations.
- Undertake all necessary training in order to achieve compliance with internal/external processes.
- Provide operational support for the Clinical Trial Strategy & Submissions team.
- Support SOP reviews and updates when required.
- Comply with the companys policies and procedures to meet statutory quality and business requirements within the overall strategy and objectives of AbbVie Ltd.
Qualifications :
Education
Bachelors degree in Medicine Pharmacy Biology Chemistry Pharmacology or related life sciences subject is required. Relevant advanced degree in life sciences is preferred.
Experience/Skills
- 12 years CTS R&D or RA experience preferable.
- Good Information Technology skills proven ability to utilise a variety of computer application packages such as MS Word Excel PowerPoint Adobe Acrobat and global databases.
- Proactive verbal and written communication style at all levels.
- Solution driven style.
- Shows high level of initiative and ability to work independently.
- Excellent communication/presentation skills written and verbal; fluency in English.
- Strong proven personal development and motivational skills.
- Strong interpersonal organisational and team working skills.
- Critical reasoning skills including the identification and resolution of complex problems and/or elevation of issues to relevant line functions and management.
- Strong Project Management skills able to manage multiple activities in line with business priorities and study time goals.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
