Specialist-Clinical Trial Strategy and Submissions

JOB TITLE: Specialist, Clinical Trial Strategy and Submissions
DEPARTMENT: Clinical Trial Strategy & Submissions (CTS)
DIRECT REPORTS: None
LOCATION: India-REMOTE
REPORTS TO: Associate Director/Manager, Clinical Trial Strategy & Submissions

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 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 non-Regulatory 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 company//'s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the organization
• Education
• Bachelor//'s degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required. Relevant advanced degree in life sciences is preferred.

Experience/Skills

• 1-2 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.