Job Opportunities in Switzerland
October 4, 2024
ITech Consult
Basel
FULL TIME
Medical Alliance Operations Leader
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:
Role: Medical Alliance Operations Leader (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.01.2024
Duration: 12++
Deadline: 10.10.2024
Job Type: 80-100%
Schedule:
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:
Role: Medical Alliance Operations Leader (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.01.2024
Duration: 12++
Deadline: 10.10.2024
Job Type: 80-100%
Schedule:
- 8 Hour Shift
We regret to inform you that this job opportunity is no longer available
Latest Job Opportunities
October 9, 2024
Gemeindeverwaltung Stäfa
Fachperson Offene Jugendarbeit (60 %)
Stäfa
PART TIME
View Details
October 9, 2024
Digitec Galaxus AG
Leiter Supply Chain Process Engineering
Zürich
PART TIME & OTHER
View DetailsSimilar Jobs
September 10, 2024
Centre hospitalier universitaire vaudois
Technicien-ne en analyses biomédicales à l'Institut de Pathologie
Lausanne
OTHER
View Details
September 13, 2024
Hôpitaux Universitaires de Genève
Secrétaire médical ou médicale au Service d'endocrinologie, diabétologie, nutrition et éducation thérapeutique du patient - 80%
Genève
PART TIME
View Details
September 12, 2024
Hôpitaux Universitaires de Genève
Technicien ou Technicienne en analyses biomédicales – 80% à 100%
Genève
OTHER & PART TIME
View Details
September 9, 2024
Basilea Pharmaceutica International
Global Medical Affairs Scientist / Manager
Allschwil
OTHER
View DetailsNew Jobs from This Company
October 4, 2024
ITech Consult
Production Expert in the value stream Solids Finished Good
Kaiseraugst
FULL TIME
View Details