Permanent - Medical Advisor - Cape Town - South Africa

Department: Medical & Scientific Affairs

Reporting to the Country Manager

Description and Aim:

As a Regional Medical Advisor you are accountable for implementing the Medical and Scientific Affairs plans in the business area of responsibility. This Role contributes to the collective Medical & Scientific Affairs implementation team of the company's product portfolio by ensuring adherence to the highest scientific, regulatory and ethical standards. This role is responsible for the management of Medical & Scientific (PV) activities in the territory/ country of responsibilities

The role provides strategic insight and advise to the regional activities. It develops and starts the implementation of strategies and tactics developed by the Medical & Scientific Affairs department in Dubai to increase medical awareness of our products’ clinical value by focusing on development of educational activities, partnerships with professionals and their associations for respective market and disease segments.

Main Responsibilities and Scope:

Medical Insight and Advice:

Identify local/regional unmet medical needs at medical and scientific customer, and address questions/concerns from the scientific communities, or propose appropriate action plan 

Lead implementation of relevant Scientific Affairs projects tot he assigned region

Deploy Medical strategy by developing regional local tactics or clinical messages for the product line of responsibility

Implement local tools to monitor medical activities and reconciliate with the M&SA department

Identify and build relationships with National Regional or International KOLs and Thought Leaders

Contribute to and support the clear articulation of a compelling brand strategy for the area of responsibility across marketing and sales functions.

Medical Information:

• Ensure all medical and product information utilized locally are in compliance with local SmPCs and local regulatory requirements and that all data provided in the provision of medical information are accurate and meet the needs of local internal and external customers,
• Assist in the organisation and support of key external National and Regional scientific events,
• Deliver lectures on scientific, clinical and technical topics spontaneously requested, and ensuring appropriate approval in relevant systems,
• Attend appropriate local scientific congresses to interact with HCPs, develop knowledge in relevant therapy areas and produce congress summaries for dissemination to internal & external stockholders.
• Support the dissemination of product and disease area knowledge across the company in accordance with business priorities,
• Undertake regular communication of best practice and facilitation of knowledge sharing cross functionally and across geographies,
• Undertake slide-deck localization and internal training initiatives in coherence with the Medical Information & Education Unit,
• Gather and report competitive intelligence information from the region/ country of responsibility

Compliance and Training:

• Ensure that all medical activities comply with company policies, guidelines, SOPs, ICH-GCP and ethical standards and local legislation,
• Identifies and contributes to areas of best practice and process improvement.
• Adhere to all applicable laws and regulations as well as to the high integrity standards as set forth by the company

Advisory Boards:

Responsible for setting up and organizing local Scientific Advisory Boards to collect input on disease areas, treatment algorithms, clinical data, and/or protocol design, and audience educational needs

Health Economics / Market Access:

Support the Access Strategy and provide data and advice to support the creation of a dossier of health economic data information for market access applications

Clinical Trial Activities:

• Provide field-based medical support to the Company's clinical research programs as required,
• Contribute to effective and efficient delivery of IIR and non-interventional studies through all phases (start-up, conduct and close down) in accordance with appropriate quality standards including ICH/GCP and applicable regulations,
• Capable to develop medically sound, feasible, study protocol, CRF, budget and site training material,
• Capable to assess IIR synopsis and grant management that enhance product knowledge,
• Ensure optimal investigators selection by a constructive dialogue between medical and clinical operations
• Ensure all local clinical trials and contracts are appropriately developed; executed within agreed timelines and budget; in accordance to Directives, SOPs, quality standards, and regulatory requirements.
• Provide direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work,
• Identifies and contributes to areas of best practice and process improvement.

Drug Safety:

• Being familiar with applicable Local/International regulations related to Pharmacovigilance and EU GVP guidelines,
• Carrying out duties according to relevant SOPs/Working Instructions/Policies as well as to applicable regulations and guidelines, with care to the quality of the work,
• Performing the Triage of all safety information and medical reviewing of all ICSRs, coming from any source, following the current procedures,
• Duly management of all documents/information regarding Pharmacovigilance in order to keep completeness, traceability and confidentiality up to the transfer to the Archive,
• Supporting the LDSUM in writing procedures related to activities performed at local level,
• Other duties as necessary at the proper scientific and technical level

Company Procedure & Follow-up Process:

Educational Background & Experience/Knowledge Required:

Education Level: Bachelor’s Degree in medicine or pharmacy, preferably with Master’s or PhD degree from a globally recognized institution.

Education Faculty / Department:  Medicine, Pharmacy or PharmaD

Work Experience: At least 3+ years of experience in pharmaceutical industry as MSL or other Medical Specialty and experience in working with business managers, clinicians, and regulatory authorities.

PRIMARY CARE background

Technical Knowledge:

• Scientific expertise in Medical Affairs activities and company relevant therapeutic areas,
• Familiar with the medical environment and healthcare system in South Africa,
• Experienced in training and coaching of colleagues.

Language:  fluent written and spoken English

Competencies and Skills:

• Knowledge in researching scientific and medical information and provide good command communication skills & presentation solutions,
• Strong ability to assess and summarize scientific and other technical information in a clear concise manner and target to a specific audience.
• Highly organized with ability to prioritize own tasks as well as those of others, good planning skills and high-level negotiating skills.
• Able to drive multiple projects with multiple priorities, as well as have the ability to strategically think through complex opportunities,
• Able to make decisions and recommendations that represent and are aligned with the overall business and product portfolio strategy,
• Ability to build productive work relationships both internally and externally,
• Ability to work effectively with cross-functional teams and influence appropriate plans and actions,
• Networking skills and the confidence to interact with senior experts on a peer-to-peer level,
• Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them,
• Analytical/ reasoning, and sound medical judgment/decision making skills,
• A willingness to keep up to date with scientific literature,
• Ability to work independently and a demonstrated self-starter,
• A high level of emotional intelligence to work effectively