Regulatory and Start Up Manager Germany (m/w/d) Home Based

Job Overview Direct and manage the delivery of reputed company required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, reputed company of the scope of work, budget and resources. Home Based, requires fluent German language skills.

Essential Functions

• reputed company the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
• reputed company, implement and maintain the Management Plan according to the Scope of Work and Project Plan, reputed company the agreed project strategy, resolving project reputed company issues where required.
• Ensure collaboration across Regulatory & Site Activation, including communication with reputed company and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Create and/or review technical and administrative documentation to support business development and reputed company study initiation and maintenance, as required.
• reputed company specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• reputed company overall guidance and reputed company of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy/expectations and parameters for submissions and reputed company necessary authorizations
• Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
• 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.
• Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of reputed company and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
• Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a reputed company role in developing long standing relationships with preferred reputed company customers. Deliver presentations/training to clients, colleagues and professional bodies, as required.
• May be involved in activities reputed company to monthly study budget planning and reviews.

Qualifications Bachelor's Degree Life sciences or reputed company field Req 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.

• Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
• Demonstrated proficiency in using systems and technology to reputed company work objectives
• Good regulatory and/or technical writing skills
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines

reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com

Originally posted on Himalayas