Offers “Sanofi”

Expires soon Sanofi

Regional Medical Governance Officer

  • Internship
  • Dubki (Simferopol Raion)

Job description



Job Description

JOB TITLE:

Regional Medial Governance Officer

REPORTS TO:

Regional Medical Head-AMEE, Tamer Pehlivan

BUSINESS AREA:

ComOps BU Medical Affairs / Functional: Global Medical

GRADE:

L3-2

DATE AMENDED

Feb.2019

JOB PURPOSE

The Regional/Country Medical Governance Officer is responsible for:

Acting as a liaison between Global Medical, Com Ops departments and the regions/countries and ensuring the implementation of medical governance guiding principles to ensure compliance with Sanofi Global, Sanofi Pasteur Global and Local standards and processes by:

·  Providing strategic and operational guidance for Medical affairs (MA) activities in his/her regional/country area in coordination with the Global Medical;
·  Providing strategic and operational guidance for Compliance with medico-marketing activities
·  Acting as the Medical governance representative for the respective region
·  Operationalizing Strategy and Key processes/Systems related to Medical Affairs activities in line with standards with and across team.

In addition, RMGOs/MGOs are expected to build strong cross-functional relationships with colleagues in Medical Affairs, Clinical Affairs, and Commercial Operations, while maintaining full compliance with all relevant company, industry, legal, and regulatory requirements.

KEY RESULTS / ACCOUNTABILITIES

List the 6-8 most important responsibilities of the job. For each key responsibility indicate the action to be taken, the end result to be achieved, and how it will be achieved. Include the % of time spent on each responsibility. Total of percent should equal 100 %.

Responsible to the Global Medical Training and Medical Governance Office for reporting and feedback regarding findings at affiliates for areas for improvement, simplification, training, or other significant topics.

Support the Global medical team to have an oversight on the medical process implementation and follow up. Medical Compliance – Promotes a quality culture through trainings such as training of medical staff on good practices (quality and compliance mindset, best medical practices, good promotional practices, regulatory obligations, etc). Ensures that all main medical activities are well implemented and followed

(i.e. Medical Information, External Expert Engagement process, Promotional Material Review, Study

Request Management process…). Supports countries for developing and implementing new SOP/processes. Medical Training – Supports the implementation of Medical Training Strategies defined by Global Medical Tools Implementation – Acts as the Regional or Country level “point of contact” for the Global Subject Matter Expert during the planning, training, roll-out, and implementation of new Medical Tools. This means each RMGO/MGO must be trained on the tool and understand its functionality and use and be able to assist the affiliate to problem solve or make decisions on best utilization of the tool. Coordinates, at the regional or country level, the implementation of the new Medical tools and ensures that key medical tools are properly implemented and used. Affairs, by rolling out the Medical Staff standard curriculums (LEAP) in the regions/countries and affiliates and tracking process on the training. Supports the Regional or Country Medical Director to adapt the training matrix according to the medical staff's role and specificity of the region. Coordinates the implementation of the On-Boarding program for new Medical Staff in each Region.

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Medical Doctor / Nurse / Pharm D

Previous significant experience in a pharma business in medical, regulatory and/or pharmacovigilance. Fluent in English, the knowledge of another language especially for the target region for assignment is a plus/asset

Able to operate within a multi-cultural environment, culturally sensitive to norms of the region or country assigned.

Extensive knowledge of Medical Affairs, MSLs, and operational knowledge of Quality Assurance, Regulatory Compliance, Pharmacovigilance science, and International Regulations and Standards. Ability to Develop, Implement, and Follow-up corrective and preventative actions following audits and inspections.

·  Frequent travels are expected for site/country visits.

The standard six core competencies are noted below. Please enter no more than six job specific competencies and their target levels.

Core Competencies

Level

Entrepreneurship

2

Change and Innovation

4

Team Performance

3

Effective Communication

4

Company Spirit

1

Strategic Thinking

3

Job Specific

Level

Customer Focus

4

Transversal Management

3

Organizational Management

3

Time Management

3

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Make every future a success.
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