Associate Regulatory Start Up Manager-Poland

Brief Position Description:

The Associate Regulatory Start Up Manager is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client’s expectations.

Minimum Qualifications & Experience:

• Graduate in a clinical, pharmacy or life sciences related field.

• At least 3 years’ experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations.

• Through knowledge of applicable regulations.

• Able to manage in a matrix environment.

• Confident decision-making and problem-solving.

• Competent working in virtual teams across time zones.

• Strong presentation, documentation, and people skills.

High proficiency in English.

Responsibilities:

• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.

• Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy.

• Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.

• Distribute start up related documents to local regulatory start up teams.

• Proactively identify any risks to start up and escalate to Project Manager.

✓   Oversee customization of core start-up documents to local requirements.

✓   Ensure preparation and distribution of core contract and budget templates to applicable team members.

✓   Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines.

✓   Oversee site activation package compilation and approvals.

• Develop RSU mitigation plans.

• Provide timely update of regulatory start up progress to Project Manager.

• Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings.

• Serve as a client’s contact for regulatory start up related items.

• Support business development by providing relevant information on regulatory start-up and attending Bid Defenses to present Novotech’ s regional capabilities.

• Ensure accurate completion and maintenance of internal systems including

• Deliver   presentation/training   to clients   and   internal/external   stakeholders regarding regulatory start up activities.

• Facilitate cooperation between cross-functional teams.

• Contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence.

• Identify   areas       of   inefficiency   in       regulatory   start   up       process   and   make recommendation for improvements.

• Represent Novotech at Industry fora (conferences, professional association, committee work, international investigator meetings).

• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

CTMS, relevant databases, and tracking tools.

Associate Regulatory Start-Up Manager (ARSM)

This role is for individuals who are new to the role of Project Manager or Regulatory Operations Manager or other leadership role within the CRO industry.

• Essential training in the areas of customer service, project management skills and regulatory and start-up technical skills will be provided at commencement of the position.

Responsibilities:

• Works with assistance from Line Manager and guidance from functional mentor to deliver start-up of projects as outlined in the core responsibilities of this document.

• Primarily manages single country or small sized projects.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

Responsibilities:

Core Responsibilities:
• Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan.
• Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy.
• Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan.
• Distribute start up related documents to local regulatory start up teams.
✓ Oversee customization of core start-up documents to local requirements.
✓ Ensure preparation and distribution of core contract and budget templates to applicable team members.
✓ Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines.
✓ Oversee site activation package compilation and approvals.
• Proactively identify any risks to start up and escalate to Project Manager.
• Develop RSU mitigation plans.
• Provide timely update of regulatory start up progress to Project Manager.
• Present at external and internal meetings including but not limited to project internal and external meetings, kick-off meetings.
• Serve as a client’s contact for regulatory start up related items.
• Support business development by providing relevant information on regulatory start-up and attending Bid Defenses to present Novotech’ s regional capabilities.
• Ensure accurate completion and maintenance of internal systems including CTMS, relevant databases, and tracking tools.
• Deliver presentation/training to clients and internal/external stakeholders regarding regulatory start up activities.
• Facilitate cooperation between cross-functional teams.
• Contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence.
• Identify areas of inefficiency in regulatory start up process and make recommendation for improvements.
• Represent Novotech at Industry fora (conferences, professional association, committee work, international investigator meetings).
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

Associate Regulatory Start-Up Manager (ARSM)
This role is for individuals who are new to the role of Project Manager or Regulatory Operations Manager or other leadership role within the CRO industry.
• Essential training in the areas of customer service, project management skills and regulatory and start-up technical skills will be provided at commencement of the position.
Responsibilities:
• Works with assistance from Line Manager and guidance from functional mentor to deliver start-up of projects as outlined in the core responsibilities of this document.
• Primarily manages single country or small sized projects.

Senior Regulatory Start-Up Manager (SRSM):
Responsibilities:
In addition to the core responsibilities outlined in this document, the SRSM will:
• Act as a coach and mentor for other RSMs and share knowledge base.
• Recognise strategic opportunities to improve RSU productivity.
• Contribute to corporate initiatives and actions that ensure the continued success of the business.
• Develop and maintain strong professional working relationships with key clients across clinical programs and portfolios.

Minimum Qualifications & Experience:
• Graduate in a clinical, pharmacy or life sciences related field.
• At least 3 years’ experience from a CRO or the pharmaceutical industry in
• Activities related to trial start-up and/or regulatory operations.
• Through knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• Competent working in virtual teams across time zones.
• Strong presentation, documentation, and people skills.
• High proficiency in English.