Regulatory and Digital Development Officer

About this role

TDT (Digital Business Transformation Task Force) is looking for a Regulatory Science & Digital Capability Development Officer to contribute to the implementation of the strategy for the EU Network Training Centre (EU NTC), and the follow-up to deliver on EMA and the European Medicines Regulatory Network’s (EMRN) strategic goals. This includes execution  of the activities of the EU NTC and the EMA Digital Academy in accordance with their roadmaps.

In this role you will

•    Execute activities relating to capability and capacity building across the European Medicines Regulatory Network (EMRN) (and its partners and stakeholders as appropriate), in the areas of regulatory, scientific, data and digital topics relevant to public and animal health in Europe;
•    Contribute to the development, definition, execution and continual adaptation of the EU Network Training Centre (EU NTC) strategy to meet evolving business and stakeholder needs;
•    Identify and gather learning and development needs and priorities in liaison with the EU NTC Training Steering Group (TrSG) and Training Champions through different methods (e.g. surveys), identify gaps in learning, and ensure provision of suitable interventions and development of learning curricula in line with such needs;
•    Work with relevant subject matter experts externally and internally to develop training curricula and to design the development and delivery of high-quality learning materials for EU Network staff;
•    In liaison with the EU NTC TrSG and Training Champions, contribute to the planning and delivery of a planned catalogue of training courses (face-to-face/virtual/e-learning) designed to meet the EU Network needs through the learning management system (LMS);
•    Contribute to the implementation of policies, standards and quality guidelines for learning design, development and delivery, carrying out research as needed;
•    Ensure the business support for the LMS, including data management creation of FAQs, implementation of agreed changes, designing processes and templates for monthly updates. This will include liaison with the Local Administrator network; 
•    Prepare reporting on the delivery of training to relevant fora, in particular to the TrSG; 
•    Contribute to the continuous improvement of the internal processes to support the EU NTC, particularly those requiring interaction with other areas of the EMA (IT, Talent Development); 
•    Conduct (in liaison with relevant EMA departments and offices) work / projects to extend (EU NTC) learning to (selected) external audiences including business case development, selection of best suited engagement platform and development of governance, processes and communication channels to include such audiences in the EU NTC learning service offering. Potential audiences include non-EU Regulators and Academia;
•    Regularly provide updates on projects / initiatives to various stakeholders / general management when applicable.

Link to the role of Regulatory Science and Digital Capability Development Officer outlining generic duties and responsibilities.

Apply if you meet these eligibility criteria

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:
 
General conditions:
1.    Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein, or Norway;
2.    Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3.    Have fulfilled any obligations imposed by applicable laws concerning military service.
 
Specific condition: 
1.    A level of education which corresponds to completed university  studies of at least three years attested by a diploma that must have been obtained by the closing date of this vacancy notice.
 
General Condition 1 and Specific Condition 1 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failure to present these documents may result in the disqualification from the selection procedure. 
 
Only eligible candidates will be assessed by the Selection Committee.

You will Need to have:

You will Need to have:

Experience

• Minimum of two years of full-time professional relevant experience.

Skills & Knowledge

• Basic stakeholder management and engagement skills;
• Good communication skills, both written and verbal;
• Basic understanding and knowledge of the relevant stakeholders/partners;

Competencies you need to have

Role competencies    

Understanding business context    Basic
Stakeholder relations management    Basic

Sub-family competencies    

Scientific communication    Basic
Regulatory frameworks & strategy    Basic
Applied knowledge    Intermediate

Grade competencies    

Adaptability and agility    Intermediate
Coping with pressures and setbacks    Intermediate
Analysing and problem solving    Intermediate

Core competencies    

Ethics and integrity     Intermediate
Team collaboration    Intermediate
Customer centricity    Intermediate
Results orientation    Intermediate
Communication    Intermediate
Cross-cultural sensitivity    Intermediate
Continuous learning and self-development    Basic

For more information about definitions of competencies and associated proficiency levels, please refer to the  EMA Competency Framework .

These are Nice to have:

Experience

• Experience as system administrator with Learning Management Systems (e.g. SAP Success Factors)
• Experience in developing training curricula/programmes/packages and/or designing, developing and delivering high-quality learning.
• Experience with e-learning authoring tools (e.g. Articulate Rise)
• Advanced IT capability with MS products
• Experience in a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting.

Skills & Knowledge

• Good project management skills
• Knowledge of the EU regulatory framework for pharmaceuticals and EU health policies
• Familiarity with the application of generative AI to learning & development
• Familiarity with the SAFe agile methodology.