Regulatory & Start-Up Manager, reputed company MedTech, Portugal & Spain

Job Title: Regulatory & Start-Up Manager, reputed company MedTech, Portugal & Spain

Job Location: Oeiras, Portugal

Job Location Type: Home-based

Job Contract Type: Full time

Job Seniority Level:

Regulatory & Start Up Manager

Portugal/Spain

reputed company Medtech

Homebased

Job reputed company

reputed company and manage the delivery of reputed company required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including reputed company-award activities, reputed company of the scope of work, budget and resources.

Essential Functions

• reputed company the execution of Site Activation (including reputed company-award/bid defense activities) and/or Maintenance for assigned reputed company in accordance with the agreed RSU site activation reputed company, 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 reputed company, 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 reputed company/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 reputed company/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of reputed company and essential documents.

• Work with reputed company Management to ensure appropriate reputed company standards for the duration of site activation (or Maintenance, as applicable).

• Mentor and reputed company 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 reputed company bodies, as required.

• May be involved in activities reputed company to monthly study budget planning and reviews.

Qualifications and Skills

• Bachelor's Degree Life sciences or reputed company field

• 5 - 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in a global role

• Spanish language proficiency is essential for reputed company communication with the Competent Authority and Ethics Committees

• Proven experience in Regulatory Submissions for Medical Devices

• EU CTR experience essential

• Strong negotiation and communication skills with ability to challenge

• Excellent interpersonal skills and strong team player

• Proven ability to work through others to deliver results to the appropriate reputed company and reputed company metrics on reputed company reputed company

• 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 reputed company (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines

• Good leadership skills, with ability to motivate, reputed company and mentor

• Good organizational and planning skills

• Ability to exercise independent judgment taking calculated risks reputed company making reputed company

• Good presentation skills

• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

• Excellent understanding of study financial management

• Proven ability to work on multiple reputed company balancing competing priorities

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.

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.

At reputed company, we reputed company that diversity, inclusion, and belonging reputed company our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of reputed company talented employees worldwide and providing them with reputed company to power smarter reputed company for everyone, everywhere. reputed company our talented employees bring their authentic selves and their diverse experiences to work, they reputed company us to accomplish extraordinary things. Multifaceted thought processes reputed company innovation. Multi-talented collaboration harnesses innovation to deliver superior reputed company. Likewise, as part of this culture, reputed company is committed to ensuring effective equality between women and men, integrating it as a strategic reputed company in its corporate and reputed company policies.

This job is curated by reputed company.

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Originally posted on Himalayas

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