Medicines Authority

Post of Documentation Officer

(Jobsplus Permit: 751/2023)

1. The Medicines Authority invites applications for the post of Documentation Officer within the Authority.

2. Terms and Conditions

2.1. The selected candidate will be employed as a Professional Officer Grade D, on an indefinite contract with the Authority, according to its Collective Agreement.

2.2. The post of Documentation Officer is subject to a probationary period of twelve (12) months.

3. Salary pegged to the post

3.1 The salary attached to the post of Documentation Officer in 2024 is that of €23,945.12 per annum.

3.2 Other benefits include a reimbursement of a maximum of €700.00 per annum for Continued Professional Development to all employees holding a degree in pharmaceutical technology or a Master of Science in Pharmacy and carrying out pharmaceutical duties, payable at the discretion of the Chairperson/ Chief Executive Officer of the Medicines Authority. Payments are subject to submission of receipts, etc. as applicable.  A Qualification Allowance (if applicable) as established by the Central Administration in line with the Medicines Authority Collective Agreement. 

4. Duties

Overall purpose

The Documentation Officer is responsible to carry out administrative duties related to the regulation of medicines, medical devices and pharmaceutical activities. The Documentation Officer shall be required to give professional service and work as part of a multi-disciplinary team.

Functions

(a)  Participate in:

–  Aministrative regulatory activities according to the exigencies of the Malta Medicines Authority and as may be required;

– Technical and administrative meetings;

– Research and development projects, as required; and

– Other ongoing projects, as required.

(b)     Provide:

– Relevant and consistent information to the Chairperson/CEO/Director/s and employees under the direction of the assigned Director;

– Regulatory and procedural support;

– Advice to the Chairperson/CEO/Director/s as required, seeking to propose strategic solutions to the challenges in this area;

– Strategic direction in the relevant assigned work in line with the strategy and vision of the Authority; and

– Technical and administrative reports, as required.

(c)     Ensure:

– Technical liaison with the stakeholders of the Authority and professional colleagues in order to facilitate the processing of assigned work;

– Compliance with the set standards, protocols, regulatory requirements and the quality management system of the Authority;

– Documentation and implementation of all policies and standard operating procedures; and

– The timely processing of tasks and issues for the respective Directorate/ Unit.

(d)     Execute duties in a professional manner:

– By keeping up to date with the knowledge required for the assigned work and related innovative technologies through ongoing training, professional education and review of the published literature;

– By operating any software package or procedure provided by management;

– Through continuous self-monitoring to improve scientific capabilities; and

– To contribute to the efficiency and effectiveness of the Medicines Authority.

(e)     Continuously improve the performance of the organisation by:

– Promoting and maintaining good professional and ethical working relationship with colleagues and             stakeholders;

– Promoting communication and liaison between different sections of the organisation;

– Representing the Malta Medicines Authority at meetings, seminars, conferences and other fora, both locally as well as       abroad;

– Observing, promoting and ensuring the effectiveness and efficiency of the quality management system;

– Training other colleagues, as may be required;

– Performing duties as may be instructed by fellow and senior colleagues; and

– Promoting the vision, mission, values, strategy and objectives of the Authority.

(f) Any other duties and responsibilities as assigned by the Chairperson/CEO and Director/s.

5. Eligibility requirements

5.1 By the closing time and date of this call for applications, applicants must be:

(i) (a) citizens of Malta; or

(b) citizens of other Member States of the European Union who are entitled to equal treatment to Maltese citizens in matters of employment by virtue of EU legislation and treaty provisions dealing with the free movement of workers; or

(c) citizens of any other country who are entitled to equal treatment to Maltese citizens in matters related to employment by virtue of the application to that country of EU legislation and treaty provisions dealing with the free movement of workers; or

(d) any other persons who are entitled to equal treatment to Maltese citizens in matters related to employment in terms of the law or the above-mentioned EU legislation and treaty provisions, on account of their family relationship with persons mentioned in paragraph (a), (b) or (c); or

(e) third country nationals who have been granted long-term resident status in Malta under regulation 4 of the “Status of Long-Term Residents (Third Country Nationals) Regulations, 2006” or who have been granted a residence permit under regulation 18(3) thereof, together with family members of such third country nationals who have been granted a residence permit under the “Family Reunification Regulations, 2007”.

The advice of the Citizenship and Expatriates Department should be sought as necessary in the interpretation of the above provisions.

The appointment of candidates referred to at (b), (c), (d) and (e) above would necessitate the issue of an employment licence in so far as this is required by the Immigration Act and subsidiary legislation. The Jobsplus should be consulted as necessary on this issue.

(ii) Proficiency in Maltese and English language;

(iii) Applicants must be in possession of a Bachelor of Science graduate degree at MFQ Level 6 in a related field or a comparable, pertinent and recognized qualifications from University/College/Institution.

Qualifications at a level higher than that specified above will be accepted for eligibility purposes, provided they meet subject requirements.

(iv) Applicants with experience in regulation of medical products will be preferred.

(v) Proven commitment to learning and development with engagement in training initiatives in the last year. 

Candidates who have not yet formally obtained the above-mentioned qualification/ registration will still be considered, provided that they submit evidence that they have been approved for the award/ registration in question by end of 2024.

5.2 Prospective applicants should note the requirement to produce MQRIC recognition statements in respect of their qualifications from MQRIC, or other designated authorities, as applicable, as per provisions applicable to this call for applications. (http://www.pahro.gov.mt/file.aspxf=799).

6. Submission of supporting documentation

6.1 Qualifications and experience claimed must be supported by certificates and/or testimonials, copies of which should be attached to the application. Scanned copies sent electronically are acceptable.

6.2 Original certificates and/or testimonials are to be invariably produced for verification at the interview.

7. Selection procedure

Eligible applicants will be assessed by a Selection Board to determine their suitability for the post.

8. Submission of applications

Applications, together with a curriculum vitae showing qualifications and experience and a signed Data Protection Consent Statement (Appendix 1), are to be submitted to hr.medicinesauthority@gov.mt by noon on 23rd March 2024.