Senior Specialist

Summary

Join Allucent™ as a Local Start-Up Senior Specialist (LSUS) and contribute to bringing life-changing therapies to patients globally. This hybrid/remote role involves coordinating and performing local site start-up activities for clinical trials. You will manage essential document collection, regulatory submissions, and communication with various stakeholders. Key responsibilities include tracking progress, filing documents, preparing regulatory documentation, interacting with authorities and ethics committees, negotiating contracts, and ensuring compliance. The ideal candidate possesses a life science degree, relevant experience, and strong communication skills. Allucent offers a comprehensive benefits package, including competitive salaries, professional development opportunities, flexible working hours, and remote work options.

Requirements

• 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 - fluency in English
• Attention to detail
• Able to perform well as a team member

Responsibilities

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

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• 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