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Mission Statement
The Mission of the Malta Medicines Authority is to safeguard public health through the regulation of medical products and pharmaceutical activities for human use.
Expression of Interest for EU reference labs for high-risk in vitro diagnostic medical devices
The Malta Medicines Authority participates in EU4Health Joint Action EU4H 11
Expression of Interest for EU reference laboratories for high-risk in vitro diagnostic medical devic
Expression of Interest for EU reference labs for high-risk in vitro diagnostic medical devices
Medicines Authority
Post of Documentation Officer
(Jobsplus Permit: 729/2020)
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 2021 is that of €22,093 per annum, rising by annual increments up to a maximum of €24,949.
3.2 Other benefits include a reimbursement of a maximum of €700.00 per annum for Continued Professional Development, 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
The Documentation Officer will work as part of a multi-disciplinary team and will participate in different regulatory and administrative duties as required and shall be required to give professional service.
Key responsibilities may include the following:
-Participating in:
• Administrative, licensing, pharmacovigilance, inspectorate and enforcement activities, according to the exigencies of the Medicines Authority and as may be required;
• Technical and administrative meetings; and
• Other ongoing projects and functions, as required.
-Facilitating processes through:
• Technical liaison with the Authority’s stakeholders;
• Advice to the Authority’s stakeholders; and
• Preparation of technical and administrative reports, as required.
-Ensuring:
• Advanced knowledge related to innovative technologies through ongoing training, professional education and review of the published literature;
• Compliance with the protocol of the Medicines Authority and regulatory requirements; and
• An effective and efficient quality management system by following and/ or reviewing the Authority’s Policies, Standard Operating Procedures and Guidelines, as required.
-Executing duties in a professional manner:
• By keeping up to date with the knowledge required for the work assigned;
• 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.
-Offering secretariat support at technical and administrative meetings.
-Continuously improve the performance and scientific image 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 Medicines Authority at meetings, seminars, conferences and other fora, both locally as well as abroad;
• Training other colleagues, as may be required; and
• Performing duties as may be instructed by fellow and senior colleagues.
-Any other duties as may be required by The Employer.
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 medicines regulation 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 December 2020.
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 Agreement (Appendix 1) are to be submitted to hr.medicinesauthority@gov.mt by not later than noon on Saturday 6 February 2021.