Head of Medical Affairs

2 weeks ago

Cape Town, Western Cape, South Africa Guardian Recruiting Full time

_Job Requirements_
Directs all medical activities and scientific activities and ensures compliance with ethical and medical legal requirements, as well as manage the Medical Affairs
Key point of contact for all external medical and scientific information
Custodian of ethical marketing conduct for the Company
Develop a medical and scientific strategy that is aligned to Company goals and objectives
Identify and communicate local medical and scientific opportunities for the organisation
Ensure that Medical Affairs related issues are on the senior leadership teams radar
Collaborate with key opinion leaders and business leaders to contribute to the development of Medical Affairs strategies that will impact the business and have relevance cross-functionally
Provide key input on thought leadership and direction in terms of Therapeutic Areas, medical opportunities, direction and concerns
Ensure that values and leadership standards are communicated and understood across all levels
Create processes to share information and experiences, leverage initiatives across the function where appropriate, and enhance productivity
Actively support development of direct reports and high
- potential colleagues within and across the Team, providing insights, direction and opportunities
Support and foster knowledge management between/across team
Ensure that all medical activities are conducted in accordance with local and corporate policies, whilst complying with national legal requirements and guidelines
Assure high medical quality and corporate ethical integrity
Liaise as needed cross-functionally to ensure medical information is in line with product development and sales / marketing strategies
Oversee the relationship with Regulatory Affairs to ensure that all written documents are accurate and adhere to mandated guidelines and that all educational, technical and promotional materials are reviewed for correctness
Facilitate the set-up of a comprehensive medical information system involving reference papers and texts that are cross-referenced on a database that is accessible to everyone
Ensure that the systems for medical information are streamlined
Ensure that the Medical Affairs function is capable of handling drug safety, reviewing individual adverse event
Ensure scientific and medical watch and expertise on company products and diseases/conditions
Ensure implementation of research and medical scientific activities in South Africa in order to contribute appropriately to the development, registration and appropriate commercial use of all our clients drugs
Participate in the strengthening of Company image toward the scientific community, health authorities, regulatory bodies and industry associations
Provide medical and scientific input to global product development teams
Oversee participation in South African scientific and guideline committees and discussion groups and analyse regular Medicines correspondence with follow-up and discussion with internal colleagues and other industry participants on relevant issues
Ensure the liaison and cross-collaboration of Medical Affairs with Regulatory, Commercial, Business Development and the Project Management Office
Ensuring that materials are reviewed for scientific accuracy and legal/regulatory compliance
Perform Health Hazard Assessment (HHA) when required
Medico-Marketing function
Support to the training department and conduct trainings
Oversee and manage the drug safety officer and drug safety activities and essential related tasks for our client in order to ensure that the company is compliant with all regulations, laws and guidelines that govern drug safety
Develop and manage stakeholder relationships in order to collaborate and align them with in order to meet functional objectives
Prove medical expertise and SAEs, to ensure drug quality and safety
Guide cross functional alignment to ensure optimal service to the business
oversee and support the Pharmacovigilance activities relating to products under the Patient Support Program
Financial forecasting for the Medical function
Annual input into business plan and budget
Track monthly spend
Generate monthly reports and report on budget variances
Manage cost control processes for medical
Manage engagement with external stakeholders relating to Medical Intelligence to understand current clinical practices, obtain medical guidance and maintain up-to-date knowledge in respective therapy areas, in order to provide valuable insights and medical support to the business
Attend Continuous Medical Education (CME)
Read relevant Journal Articles
Attend congresses
Attend medical forums
Attend round tables
Attend Conference
Attend Symposia
Focus groups
Product & disease entity info

_Minimum Requirements_
Medical Doctor
Minimum 8 years of experience in Medical in the Pharmaceutical Industry
Hands-on experience in Medical Affairs

All job postings are in accordance with our Client's BEE requirements

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