Website The Biovac Institute
The Biovac Institute requires a Medical Affairs Officer to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub-Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.
The successful incumbent will report to the RP/RA Manager
Key Duties & Responsibilities
- Setting up of Medical Affairs section that supports Biovac and the Kahma Group of companies. (Supports WHO pre-qualification, local and export legislation)
- Set up and maintain Medical Affairs policies and procedures and provide Medical Affairs oversight and compliance through the establishment of appropriate programs as defined by local and legal frameworks for SAHPRA (MCC), Sub Sahara African markets and WHO pre-qualification and establish effective relationships with the clinical sections of the relevant NRA.
- Identify, implement and maintain group wide Medical Affairs Policies and procedures that supports clinical trials for new and existing products.
- Establish an annual Medical Affairs budget
- Responsible for all stages of clinical development of company’s project including CRO / other vendors selection (with Procurement, Bids & Contracts) and CRO day to day management including study design, initiation and monitoring protocol development coordination, biostatistics and clinical study reports supervision.
- Provide relevant clinical and medical input into the companies’ various commercial programs e.g. business development and product development.
- Liaise with regulatory authorities, internal and external stakeholders such as HCPs, patient’s, business partners and represent the company across a range of Clinical forums.
- Provide Medical oversight for Pharmacovigilance Risk Management plans for the introduction of new registrations into markets.
- Provide relevant Clinical Trial and Medical Affairs input to pharmacovigilance for new and existing product portfolios.
- Respond promptly with medical investigations for ADR’s / PVRM within the prescribed applicable regulatory timeframes
- Follow up with medical professionals on queries and investigations.
- Medical communication between the company and external stakeholders such as HCPs, professional organizations, disease state advocacy groups patients and health authorities
- Provide Medical information for vaccines and providing insight into the commercial development of products.
- Provide scientific input, expertise and review in the design and construction of all promotional materials, DHCP letters, package inserts, market research, advisory boards and events.
- On request present relevant scientific information at marketing / scientific related functions.
- Contractual oversight: Ensure appropriate Medical agreements are in place with Contract Giver / Contract Acceptors and that they are regularly reviewed and maintained.
- Identify / Implement / Ensure / Provide on-going Product training for employees and healthcare providers.
- Prepare for audits and have plan of action in place before audits.
- Ensure Medical Affairs services are delivered to all internal and/ or external stakeholders as defined and as per departmental and/ or business calendar.
- Actively engage all non- performance issues regarding service delivery
- Carry out responsibilities in accordance with the organizations’ policies, industry standards and applicable laws.
- Ensures compliance in accordance with (Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974) and the organizations policies, procedures and other applicable laws.
- Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac
- Shared accountability for achieving the site’s tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.
- Identify and continuously present key opportunities and synergies that will improve and/ or expand the operation within own and/ or other departments.
- Lead or participate in departmental and/ or site wide projects
- Monitoring & reporting on key operations, critical numbers and key performance indicators that impacts the business’s short, medium and long term objectives.
- Participate with the site management team in proactively mitigating risks and find solutions where possible
Technical Competencies required to perform this aspect of the role:
- KPI Development
- Resource & Capacity Planning & Management
- Coaching & Mentoring of peers & staff
- cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
- Total Quality Management & Quality Management Systems
- Data development, trending & reporting
- Coaching & mentoring peers & staff
- Excellent understanding and working knowledge of Medical / Regulatory and Clinical Trial systems.
- Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Clinical Trials
- Documentation Management
- Inventory Management
- Environmental, Health & Safety Management
Generic Competencies required
- Planning, Organising, Execution & Delegation
- Strategic & Holistic Thinking
- Creative Problem Solving & Innovation Skills
- Sustainable Stakeholder Management
- Financial Acumen
- Commercial Awareness
- Action & Results Oriented
- Assertive & Resilient
- Adaptable in Responding to change
- Negotiation and influencing skills
- Proactive in mitigating risk
- Clear, timely and effective communication skills both verbally and in writing
- Analytical Ability
Supporting Quality Management
- Building own cGMP knowledge and compliance.
- Participate in achieving the company’s quality objectives.
- Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
- Ensuring audit readiness within own role through closing out audit findings timeously.
- Ensure Deviations, Change Controls, CAPAs are handled effectively.
- Advocate continuous improvement.
Knowledge & Experience
– At least 2- 3 years’ experience in clinical affairs and clinical trial management.
– At least 2-years’ experience in strategic engagement with Key Opinion Leaders in Clinical Medicine.
– At least 1 year of Pharmacovigilance experience
– Operational planning.
– Project management
– Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources.
Strong background in the vaccine / biotech / pharmaceutical sector specializing in medical/medico-marketing functions, working knowledge of Pharmaceutical
- MBChB minimum
- Post graduate qualification in clinical medicine or business administration
- Recognition is given to Prior Learning and practical experience.
Potential shift work, own reliable transport, ability to conduct road and air travel nationally and internationally
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress.
Interested persons to kindly submit their CV’s to firstname.lastname@example.org by 20 October 2018
Kindly note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business