Medical Alliance Operations Leader (m/f/d)

Medical Alliance Operations Leader (m/f/d) - ISO 14155 / ISO 20916 / ISO 13485 / Pharma / English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Medical Alliance Operations Leader (m/f/d).

Background:
We are seeking a highly motivated and experienced Medical Alliance Operations Leader to join our team. In this role, you will be responsible for overseeing the development and implementation of clinical research processes for drugs and devices, ensuring compliance with regulatory standards and requirements. The ideal candidate will have substantial experience with ISO 14155, ISO 20916, and ISO 13485, as well as a strong understanding of global regulations such as 21 CFR 812, IVDR, and MDR.

The perfect candidate:
The perfect candidate: holds a Bachelor's degree, preferably in Natural or Life Sciences, with a minimum of 3 to 5 years of relevant experience in the pharmaceutical or medical device industry. The person has a proven expertise with ISO 14155, ISO 20916, and ISO 13485, along with in-depth knowledge of drug, IVD, device combination, and multi-standard studies and is fluent in english.

Tasks & Responsibilities:

* Process Development and Implementation: Develop, optimize, and implement clinical research processes and procedures to ensure efficient and compliant study conduct.
* Process Infrastructure Development: Establish and maintain process infrastructures to support clinical research activities.
* Process Oversight and Quality Management: Monitor and manage clinical research processes to ensure quality and compliance with applicable regulations and standards.
* Study Team Coaching and Training: Provide guidance, training, and support to study teams to enhance their understanding of clinical research processes and regulatory requirements.
* Support Inspection and Audit Preparation and Follow-up: Prepare for and support inspections and audits by regulatory authorities and other external stakeholders; manage follow-up actions as necessary.
* Issue and Finding Management and Resolution: Identify, investigate, and resolve issues and findings related to clinical research processes.
* Stakeholder Management and Engagement: Engage and collaborate with internal and external stakeholders to ensure smooth and effective management of clinical research activities.
* Communication and Interpersonal Skills: Demonstrate strong communication and interpersonal skills to effectively convey information and build relationships with stakeholders.

Must Haves:

* Education: minimum Bachelor level ideally in Natural/Life Sciences
* Minimum 3 to 5 years of relevant experience in pharmaceutical or medical device area
* Proven experience with ISO 14155, ISO 20916, and ISO 13485
* In-depth knowledge of drug, IVD, device combination, multi-standard studies, and combined studies
* Awareness of applicable global regulations (21 CFR 812, EU IVDR, EU MDR).
* Strong skills in process development, implementation, and infrastructure development.
* Excellent process oversight and quality management capabilities.
* Experience in coaching and training study teams.
* Proven track record in supporting inspection and audit preparation and follow-up.
* Strong problem-solving skills and experience with issue and finding management and resolution.
* Excellent stakeholder management and engagement skills.
* Superior communication and interpersonal skills.
* Business fluent in English
Nice to have:


Reference Nr.: 923699TP
Role: Medical Alliance Operations Leader (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.01.2024
Duration: 12++
Deadline: 10.10.2024

If you are interested in this position, please send us your complete dossier.