***Senior Regulatory & Start-Up Specialist (f/m) - office based in Frankfurt or Freiburg/Br.***
Manage and perform tasks at country level associated with Regulatory, Start-Up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines, including pre-award activities, oversight of the scope of work, budget and resources.
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines. Where applicable, act as a Country Lead for projects with no regional/global Lead assigned.
- Collaborate and communicate across departments to successfully deliver the agreed project scope in compliance with the agreed project plans and procedures.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. Ensure overall project efficiency and adherence to project timelines and financial goals; report project and site performance metrics and out of scope activities as required.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.
- Perform pre-award activities including attendance at bid defense reviews and sales meetings and support with material/presentations, review of proposals and reviews of the scope of work at country level. May provide input into budget development.
- 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.
- Work with Quality Management to ensure appropriate quality standards for the duration of the project.
- Mentor and coach colleagues as required, and prepare and deliver country-specific training, for less experienced staff.
- May provide input into contract and budget template development.
- May review, prepare and negotiate site contracts and budgets with sites, as required.
- May deliver presentations/training to clients, colleagues and professional bodies, as required.
- May be assigned to local/regional/global process improvement working groups.
- May act as Country Regulatory Ethics and Contract Expert and reviewer of ICF.
- May participate in feasibility and/or site identification activities; May perform Site Selection Visits if trained as a monitor.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Fluent German language skills and very good English language skills
- Good negotiating and communication skills with ability to challenge.
- Good interpersonal skills, a strong team player.
- Good regulatory and/or technical writing skills.
- Thorough understanding of regulated clinical trial environment and knowledge of drug development process.
- Proven ability to exercise independent judgment taking calculated risks when making decisions.
- Good leadership skills, with ability to motivate, coach and mentor.
- Good organizational and planning skills.
- Good presentation skills.
- Excellent understanding of study financial management.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Knowledge of applicable regulatory requirements, SOPs and company’s corporate standards.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences or related field, with 5 years’ relevant experience including demonstrable experience in acting as the main local lead in studies or equivalent combination of education, training and experience.