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OMA Compliance & Governance Training Lead

Posted on Sep 10, 2019 by Harvey Nash IT Recruitment Switzerland

Basel, Switzerland
Immediate Start
Annual Salary

For our client in Basel we are looking for OMA Compliance & Governance Training Lead for 12-month contract.

Job title: OMA Compliance & Governance Training Lead (OMA = Oncology Medical Affairs)

Duration: 01/10/2019 to 30/09/2020

Location: Basel

Workload: 100%

OMA = Oncology Medical Affairs

Key Accountabilities:

OMA Compliance & Governance Training
1. Lead design and implementation of "Just-In-Time (JIT)" training concept for OMA in 3Q
2. Operate and monitor execution of JIT training in 4Q+
3. Advise Pharma Medical Affairs on JIT training implementation (TBC)
4. Support OMA Global GxP Director on training management and operations (incl assignments and training compliance monitoring)

1. Provide ad-hoc support to key projects (namely GEMS rollout, HCP Experience)

Professional and Technical Requirements:
Minimum: Scientific qualification (PhD, MSc or Bachelor's Degree) in in an appropriate scientific discipline or quality-related field with an in-depth knowledge of the international pharmaceutical product development process
A minimum of 2 years' experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities.
Expertise in the principles and practices of Quality Risk management and/or GxP audits

Experience, Skills, Knowledge:

Strong analytical and planning skills
Able to understand and work with enterprise and functional systems & data
Experienced in implementing and deploying projects/changes in an organization
A broad understanding of Quality Management, GCP/GVP and Risk Management processes
A broad understanding of main Health Authorities standards (eg FDA, EMEA) and ICH regulations and guidelines.
Proven self-starter with experience in building capabilities based on defined business needs across geography and functions.
Fluent in written and spoken English. Strong and confident communicator both internally at all levels and externally with outside and industry bodies.

Must have is Pharma experience;

FDA Knowledge is an Advantage
Familiar with Quality management, Risk management, documentations in a compliant way.
Hands-on experience

For further details please contact:
Anna Siemienkiewicz
(see below)

Reference: 754762947

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