Deputy Director: Medicine Control (Clinical Trials) (Reference NDOH 28/2013)

Advertiser: National Department of Health

Location: Pretoria

Salary: Grade 1: R624 423 per annum (plus competitive benefits) Originally certified certificates of service must be submitted with your application as well as proof of registration as a Pharmacist (where applicable).
Centre: Chief Directorate: Food Control, Pharmaceutical Trade and Product Regulation.
Directorate: Clinical Evaluation and Trials. Pretoria.

Requirements:
- B. Pharm degree and Registration as Pharmacist
- A post-graduate degree in Pharmacology, Clinical Pharmacy or Pharmacoepidemiology will be an advantage
- At least five (5) years experience in a regulatory environment
- Knowledge of the Public Finance Management Act (PFMA), Public Service Regulations Act, Labour Relations Act and Employment Equity Act
- General and financial management and supervisory experience
- Knowledge of Good Clinical Practice (GCP) guidelines and SA GCP guidelines as well as extensive knowledge of the Medicines and Related Substances Control Act as amended and its related Regulations with respect to the regulation of medicines in terms of quality, safety and efficacy
- Knowledge of database management will be an added advantage
- Computer skills as well as good communication (written and verbal) and interpersonal skills
- Project management, organisational and planning skills
- Must be willing to work irregular hours and under pressure
- A valid driver’s licence.

Duties:
- Manage clinical trial related activities
- Oversee clinical trial committee meeting arrangements
- Develop and update Standard Operating Procedures for conducting clinical trials, guidelines and policy documents (including technical)
- Keep accurate records of clinical trials related activities and oversee maintenance of the clinical trial database
- Participate in the processing of new Clinical Trials applications (unregistered medicines, registered medicines and amendments) including allocation to reviewers
- Liaise with applicants, Clinical Trial Committee (CTC), Medicines Control Council (MCC) members and other Medicines Regulatory Authorities
- Attend CTC and MCC meetings
- Compile submissions to senior management
- Provide input on parliamentary questions regarding clinical trials
- Supervise compilation of committee and council documents on clinical trials and execution of recommendations and resolutions thereof
- Evaluate clinical trial applications, responses, progress reports and assist with the evaluation of protocol amendments
- Co-ordinate clinical trial activities and committee meetings
- Supervise, guide and train technical and administrative staff
- Manage staffing arrangements in the unit
- General management, financial management, budgeting and human resource management
- Build clinical trial review capacity in the sub-directorate
- Follow-up with external evaluators in order to manage time lines
- Perform other functions that may arise from time to time.

Enquiries: Ms P. Nkambule tel no (012) 395 8126 / 9470

The Department of Health is registered with the Department of Labour as a designated Employer and the filling of the following posts will be in line with the Employment Equity Act (including people with disabilities).

Applications:
The Director-General, National Department of Health, Private Bag X828, Pretoria. 0001. Hand delivered applications may be submitted at Reception (Brown application Box), Civitas Building, corner of Thabo Sehume (formerly known as Andries) and Struben streets, Pretoria.

For attention: Ms N Sombinge

Note:
Applications should be submitted on a Z83 form (click to download pdf form) and should be accompanied by a CV (previous experience must be comprehensively detailed) and certified copies of qualification certificates, service certificates, including ID and driver’s licence. No faxed or e-mailed applications will be considered. Applications received after the closing date and those that do not comply with the requirements will not be considered. It is the applicant’s responsibility to have foreign qualifications and national certificates (where applicable) evaluated by the South African Qualification Authority (SAQA). The department reserves the right not to fill the post. The successful candidate will be subjected to personnel suitability checks and other vetting procedures. Applicants are respectfully informed that correspondence will be limited to short-listed candidates only. If notification of an interview is not received within three (3) months after the closing date, candidates may regard their application as unsuccessful. The Department will not be liable where applicants use incorrect/no reference number(s) on their applications.

Reference number: NDOH 28/2013

Closing date: 6 May 2013