Precision For Medicine

Compliance

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs

Regulatory Manager – Senior Regulatory Manager

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents for submission to Regulatory Authorities and/or Ethics Committees
• Serve as representative of Global Regulatory Affairs at project team meetings
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets

Manager

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Senior Contracts Manager – FSP

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
• Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
• Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
• Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
• Provides ICH GCP guidance, advice and training to internal and external clients
• Serve as representative of Global Regulatory Affairs at business development meetings

Regulatory Manager / Senior Regulatory Manager

• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments.
• Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines.
• Serve as a subject matter expert within the department and company regarding site contract management.
• Establish process and procedures for overall site contract management in the organization.
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations.
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.

Regulatory Manager – Senior

• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments.
• Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines.
• Establish process and procedures for overall site contract management in the organization.
• Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts.
• Escalate and resolve complex issues with clients and internal stakeholders.
• Negotiate site budget.
• Provide guidance to business teams regarding operational implications of contract terms.
• Ensure adherence to company policies, procedures and contracting standards.
• Update relevant study team members regarding the status of contract negotiations and execution.
• Establish, track, report and manage site contract metrics.
• Coordinate execution of agreements and track agreement expirations and other obligations.
• Support the maintenance of contract files and databases, including contract archiving.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Recognize where processes can be improved and take corrective action.
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
• Other tasks, as assigned.

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• Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments
• Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines
• Establish process and procedures for overall site contract management in the organization
• Review, draft and negotiate agreements including site contracts, confidentiality agreements, and other client contracts
• Escalate and resolve complex issues with clients and internal stakeholders
• Negotiate site budget
• Provide guidance to business teams regarding operational implications of contract terms
• Ensure adherence to company policies, procedures and contracting standards
• Update relevant study team members regarding the status of contract negotiations and execution
• Establish, track, report and manage site contract metrics
• Coordinate execution of agreements and track agreement expirations and other obligations
• Support the maintenance of contract files and databases, including contract archiving
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts
• Recognize where processes can be improved and take corrective action
• Mentor and/or Ambassador for new SCMs and Precision for Medicine staff

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.

Principal Regulatory and Start Up Specialist

Research Analyst

• Monitor and own the progress of clinical studies at investigative sites.
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
• Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Clinical Research Associate I/II

Clinical Research

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Clinical Trial Manager

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