Group Lead – Medical Advisor – Fixed Term Contract 408 views

Job Overview

  • Salary Offer Market Related
  • Experience Level Manager
  • Total Years Experience 10-20

Purpose:

A multi-national pharmaceutical company manufacturing world class generic medicines is seeking a Group Lead Medical Advisor who will develop, control and shape strategies for all therapeutic areas, provide and ensure dissemination of ethical, scientifically correct and balanced information for execution to the respective stakeholders, provide cross-functional support to relevant business units, and build, support and maintain the company brand

Minimum Requirements:

  • MBChB Bachelor of Medicine and or Bachelor of Surgery degrees or equivalent and registration with the HPCSA as an independent practitioner
  • 6 to 8 years’ experience
  • 3 years’ experience in a Medical Affairs role in the pharmaceutical industry is preferred Overall experience of Clinical decision making and pharmacology knowledge will be an added advantage

Key Job Outputs:

Accountability Cluster

  • Providing medical support to the commercial marketing and sales team with the relevant information to contribute to the execution of the commercial strategy to achieve business objectives for SA and SSA
  • Developing a comprehensive commercial strategy in partnership with the commercial team, based on a clear understanding of available data, key competitors, current medical practices, trends and patient needs for existing including new products
  • Executing the commercial strategy
  • Providing scientific support for the creation of marketing material for existing and new products
  • Guiding, reviewing and approving all marketing, educational, corporate communication and training material in accordance with applicable laws, regulations and internal procedures
  • Responding and resolving the concerns or issues arising from marketing activities
  • Mitigating potential risks arising from commercial activities
  • Formulating a scientific agenda and identifying appropriate speakers for various medical CMEs, scientific meetings including round table discussions

Training

  • Creating relevant clinical training material for therapeutic areas
  • Evaluating and reviewing all training content
  • Training new and existing sales representatives to build capacity by providing a deeper understanding of the disease therapeutic area
  • Training other staff members to improve skill sets, when required

Provide support to Regulatory Affairs

  • Providing the scientific input required to ensure dossier submission
  • Providing the scientific input for appropriate responses to regulator queries raised
  • Conducting clinical motivations for molecule registrations such as expedited reviews
  • Providing guidance for regulator-related communication for medical reviews of updated package insert information

Key Interactions

Internal

  • Marketing and sales, packaging, portfolio, compliance, legal, corporate, creative department, regulatory affairs and the training department

External

  • Government officials, regulator, marketing, PR and digital media agencies, medical and nonmedical institutes and key opinion leaders

General

  • Contributing to pharmacovigilance in SA and SSA by line management of the Drug Safety Officer and providing medical expertise, facilitating reporting, evaluation of product complaints with respect to quality and SAEs to ensure drug quality and safety
  • Ensuring that product-related complaints are forwarded to the DSO/QA team for appropriate action
  • Providing the necessary medical expertise to the DSO to evaluate SAE’s
  • Supporting the DSO in ensuring regular training of employees in accordance with company procedures and relevant guidelines
  • Coordinating with the external stakeholders such as doctors, patients and pharmacists to obtain the necessary information in critical cases
  • Supporting the DSO in ensuring that safety data exchange agreements are in place and that all 3rd parties are aligned to company procedures and compliant with the relevant legislation
  • Reviewing monthly PV reports and submissions to the regulator
  • Supporting the development of a robust portfolio by identifying gaps, understanding and keeping abreast of the changing therapy landscape to have an appropriate product mix and pipeline for the company
  • Remaining abreast with the latest therapy market trends by continuously reading related material and attending national and international conferences
  • Evaluating and suggest new products to SA and SSA business teams in line with the changing treatment paradigms and new developments in therapy, guidelines and modalities
  • Suggesting incremental innovations for lifecycle management of marketed products
  • Reviewing and providing medical opinion on products that are suggested by other stakeholders such as business development, portfolio and commercial for SA and SSA
  • Participating in discussions for in-licensing of products with prospective clients
  • Participating actively with the project management office activities for all product launches
  • Providing continuous medical knowledge development and maintenance for therapeutic areas
  • Identifying and developing key relationships within the company
  • Developing and maintaining contacts with local and international key opinion leaders, clinical investigators, policy makers and all potential stakeholders that influence the business
  • Continuously engaging with key opinion leaders to ensure successful roll-out of medical and marketing initiatives
  • Initiating and conducting scientific advisory board meetings when needed
  • Maintaining the dialogue on appropriate utilisation of products
  • Collaborating with key medical institutes and professional societies
  • Building and strengthening the company image and business opportunities by interacting with the scientific community, health authorities, regulatory bodies and industry associations
  • Attending various medical forums, congresses, conferences, round tables, journal clubs, symposia and continuous medical education events to keep track of developments in therapeutic areas
  • Engaging with the health care funders on a health and pharmacoeconomic level to assist the company with marketed products formulary referenced
  • Manage the process to provide unapproved products in South Africa via the Regulator’s Section 21 process
  • Managing patient support programmes
  • Participating in development programmes such as the Young Managers Programme
  • Providing the necessary medical expertise for special projects
  • Preparing the medical budget and ensuring adherence to the approved budget
  • Guiding, reviewing and approving all marketing, educational, corporate communication and training material in accordance with applicable laws, regulations and internal procedures
  • Drafting and reviewing SOPs
  • Providing medical support for new product launches
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Contact Details

Address: 1 Maxwell Drive | Sunninghill | Johannesburg | South Africa

Email: info@velapersonnel.co.za

Contact Number: 011 802 0185

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