Start-Up Associate II (Italy)

Allucent; Lombardia; Híbrido; EUR 42 000 - 62 000; Tempo integral

Resumo da oferta

Allucent is seeking a Start-Up Associate II to join our A-team in Italy with hybrid/remote work options.

The SUA II coordinates local site start-up activities, manages regulatory submissions, and acts as the main liaison to regulatory authorities and investigators during the initial phase of a clinical study.

You will track milestones in CTMS, maintain essential documentation, and support regulatory and ethical submissions to enable timely Site Initiation Visits.

Qualificações

• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• Thorough knowledge of country/region submission and reporting requirements and guidelines.
• Thorough understanding of the drug development process.
• Excellent oral and written communications skills; fluent in Italian and English.
• Attention to detail and ability to work well in a team.

Responsabilidades

• Coordinate local start-up activities and regulatory submissions.
• File documents in the (e)TMF and maintain CTMS data.
• Prepare, compile, submit and maintain regulatory documentation for local approvals.
• Assist in preparing country-specific essential documents and respond to agency questions.
• Interact with regulatory authorities and IEC/IRB; ensure compliance with local regulations.

Conhecimentos

Fluent Italian & English

Formação académica

Life Science degree or equivalent

Regulatory affairs certification (related)

Descrição da oferta de emprego

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

In this roleyour key tasks will include:

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)

• Ensure planned dates are reliable and up to date in CTMS departments/study teams

• File documents in the (e)TMF for which they are the document owner

• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner

• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level

• Provide relevant documents in compliance with local regulation

• Support review of technical, pre-clinical and clinical reports for regulatory submissions

• Interact with regulatory authorities

• Prepare and compile answers for questions raised by the regulatory agencies and submit the answers

• Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate

• Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed

• Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level

• Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation

• Interact with IEC/IRB

• Prepare and compile answers for questions raised by the IEC/IRB and submit the answers

• Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate

• Assist in adapting country SIS/ISF to site-specific requirements

• Provide country specific requirements to GSCM impacting site contracts’ process

• Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study

• Negotiate within client approved contract and budget templates and negotiation parameters

• Communicate with sites and internal personnel regarding the status of contracts and contract related documents

• Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable

• Provide the final/draft CTA and site budget for submission, where required

• Obtain site signature as well as Sponsor/Allucent signature, as applicable

• Keep up to date with applicable local regulations impacting clinical trial contracts

• Assist in preparing the site-specific Essential Document Package and sending to sites

• Responsible for collection and first review of Essential Documents

• Provide the Global Essential Document Reviewer with the collected documents for independent review

• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution

• Obtain authorization for the shipment of Investigational Product to the site

• Track relevant information and data in CTMS and/or other tracking tools

To be successful you will possess:

• Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
• A thorough understanding of the drug development process
• Good oral and written communications skills - fluent in Italian and English.
• Attention to detail.
• Able to perform well as a team member.

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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