Sr Regulatory & Start Up Specialist, cFSP

Sr Regulatory & Start Up Specialist Mexico

Full home-based

Job Overview

The Sr Regulatory & Start Up Specialist or SSO Study Start-Up Manager is accountable for study planning SSU activities and activation deliverables of assigned projects in compliance with Novartis processes GCP/ICH and regulatory requirements in a standalone country OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study satellite countries acts as primary back-up and deputy of the country manager.

Essential Functions

• Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead SSO Country Head Portfolio / SSO Cluster Head Portfolio

• Collaborates with SSO Country / Cluster Head Portfolio SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments

• Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects

• Ensures close collaboration with local IRBs/IECs and Health Authorities as applicable

• Ensures that study start-up activities are conducted and completed on time including preparation of IRB/IEC submission packages review of Informed Consent Forms engaging Regulatory Affairs/CTA Hub for Health Authorities submissions as required

• Prepares and finalizes local submission package for submission to IRB/IEC CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments IBs DSURs CSRs)

• Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable

• Accountable for timelines accuracy and quality of country TMF documents in study start-up to ensure TMF inspection readiness

• Ensures adherence to financial standards prevailing legislation ICH/GCP IRB/IEC Health Authority and SOP requirements

• Implements innovative and efficient processes which are in line with Novartis strategy

• Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.

• Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned

• Leads/chairs local SSU team meetings in assigned studies participates in global study team meetings as required

Qualifications

• Bachelors Degree in Life Science or related field or work experience equivalent.

• Minimum of three years of relevant experience in the biopharmaceutical/CRO industry including experience in EC submission in Mexico.

• ICF customization experience

• Fluent English: written and oral communication skills

• Proficiency with Veeva Vault and all applications of Microsoft Office.

• Ability to negotiate complex contract and payment terms.

• Goal oriented self-starter with proven ability to work independently.

• Able to proactively identify issues and provide potential solutions for resolution.

• Detail oriented.

• Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.

• Good interpersonal skills

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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