Fernanda Zolin Email & Phone Number

Cincinnati, Oh, Us

Cincinnati, Oh, Us

Morrisville, Nc, Us

Morrisville, Nc, Us

Raleigh, North Carolina, Us

Raleigh, North Carolina, Us

Raleigh, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

- Oversee the execution of Start Up (including pre-award/bid defense activities) for assigned projects in accordance with the agreed strategy. - Develop, implement and maintain the Start Up Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy. - Ensure collaboration across Start Up staff, including communication with regions and countries, to successfully deliver the agreed project scope. - Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. - Create and/or review core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required. - Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. - Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required. - Work with Quality Management to ensure appropriate quality standards for the duration of the project. - Mentor and coach colleagues as required. - Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. - Develop long standing relationships with customers. - Deliver presentations/training to clients, colleagues and professional bodies, as required.

Durham, North Carolina, Us

- Serve as global regulatory lead. - Serve as regional (Latin America) regulatory lead. - Prepare specific project instructions. - Oversee the tasks performed by local regulatory experts, providing any necessary support and being the interface between the local team and sponsor. - Attend to sponsor meetings such as BID defense, Kick-off and investigator’s. - Ensure the local regulatory experts are working accordingly with the scope of the project, identifying out of scope activities and informing the Project Manager of any necessary changes to the assigned budget.

Durham, North Carolina, Us

- Review and approve of IP Release packages. - Coordinate regulatory documents required for IRB and MoH submissions and/or approvals. - Serve as local (Brazil) or regional (Latin America) regulatory lead. - Attend to Kick-off Meetings.

Durham, North Carolina, Us

- Provide support to the Sponsor, Q team and study sites (through e-mail correspondences, telephone contacts, teleconferences and face-to-face meetings) to obtain regulatory documents and/or information needed for IRBs and MoH submissions and/or approvals, including close follow-up of the regulatory submissions and/or for obtain regulatory approvals. - Assist in the preparation of regulatory documents required for IRB and MoH submissions and/or approvals. - Review regulatory documents provided by the Sponsor, Q Team and/or study sites for legibility, completeness, and accuracy and compliance with applicable regulations. - Translate documents, proofread translated documents or handle outsourcing translations. - Compile, track, and organize study documents. - Distribute regulatory documents, publications, and other relevant materials. - Provide training to new hires. - Prepare regulatory documents required for IRB and MoH submissions and/or approvals.

- Development of projects in the Cosmetics and Alimentary areas.- Development of activities related to project development, provide technical support to consultants on their projects.- Organize regular meetings with staff to monitor progress of projects and consults. - Meetings with potential clients, clients and other Junior companies.

Master Of Business Administration (Mba), Human Resources Management/Personnel Administration, General

Bachelor, Pharmacy & Biochemistry