Job Description

Full Time Gauteng, Johannesburg November 3, 2023 - December 3, 2023 Healthcare Professionals

Job Overview

Requirements:

• Doctor of Medicine degree
• Preferably specialising in Oncology or Neurology
• At least 7-10 yearsxe2x80x99 experience in Medical Affairs/Regulatory Affairs
• Extensive product and disease knowledge
• Strong personal commitment and customer focus
• Excellent interpersonal communication, negotiation, and advanced presentation skills
• Knowledge of regulatory rules and processes
• Knowledge of clinical trials rules and processes
• Knowledge of good clinical practice standards
• Strong adherence to PHAP Code of Pharmaceutical Marketing Ethics
• Living the values of Integrity, Respect, Patient-Centric, Accountability and Excellence
• Driverxe2x80x99s license
• Medical Doctorxe2x80x99s license

Core Competencies: HHC and Compliance:

• Serves as a role model in embodying our clients mission of HHC and compliance and consistently promotes strategies in line with that commitment

Integrity:

• Models, leads, trains, and motivates peers to have a high level of trustworthiness
• Demonstrate strength of integrity in the business decision-making to harness and cultivate behaviour across the organisation

Customer Focused:

• Creates opportunities to strategize with customers, showing how their needs can be met by our client, and ensures continued customer satisfaction

Patient Centric:

• Holds others accountable for making decisions, setting the direction, or developing products, programs & services that are in the best interest of patients/and or caregivers

Strategic Thinking:

• Creates strategies for the affiliate based on a careful analysis of customers, markets, competitors, resources, and a deep understanding of regional strategies in ALA
• Anticipates changes, proactively addresses the risk/challenges and creates sustainable business strategy

Insights & Analytical Thinking:

• Employs a data-driven approach to evaluating business opportunities or to reach business decisions
• Balances qualitative and quantitative data or information in the decision-making process

Entrepreneurship:

• Creates a culture where ideas and suggestions are encouraged and nurtured

Innovation Excellence:

• Shares new approaches from inside and outside the organisation with others to promote knowledge exchange within the organisation
• Fosters and leads innovation from people, process and systems

Effective Planning:

• Develops plans to achieve organisational long-term objectives while consistently identifying sub-goals and action items that are realistic

Result Orientated:

• Anticipates major roadblocks including potential risks in the organisation and finds ways to avoid them by utilising various resources in the organisation or ALA

Industry Expertise:

• Has a deep understanding of the pharma industry and business in the ALA regional market

Self-Directed Learning:

• Builds internal and external relationships to gain and check information regarding strategies and also establishes an environment to share own knowledge inside the organisation

Coaching:

• Provides one to one support to employees across all organisation levels, and able to train others in coaching techniques

Talent Development:

• Creates a learning culture where development is a priority at all levels in the organisation
• Proactively drives talent development agenda for the organisation to remain competitive and sustainable in talent management

The main purpose of this position: Responsible and accountable for medical affairs department, pharmacovigilance, drug safety reports, local clinical trials, adherence to compliance policies, FDA regulations, IFPMA & PHAP Codes of Pharmaceutical Marketing Practices, and conduct of product and disease training
Duties & Responsibilities: Control & Governance:

• Formulates and develops medical policies and strategies that uplifts our client as a medically relevant pharmaceutical company in the Philippines
• Ensures adherence to laws and regulations
• Supports Regulatory Pharmacist on initial and renewal of product registration with FDA, and handles other FDA regulatory issues requiring Medical Directorxe2x80x99s attention
• Leads or facilitates the conduct of clinical trials supported by the company, i.e. post marketing surveillance studies for registration purposes, local clinical trials, and investigator sponsored trials, and develops trial protocols based on good clinical practice standards
• Abides by pharmacovigilance policies. Monitors and submits reports on adverse events, if any, to FDA, Client, (ECL), and other concerned local and international regulatory agencies
• Serves as spokesperson for our client in the media involving medical and product issues, product recalls and similar concerns

Strategy Development:

• Takes on a partnering role to top management on company strategies and directions e.g., possible new indications for existing products as input for product cycle management
• Advises Sales and Marketing management in the formulation of marketing plans and strategies for existing products, as well as in the successful launch of new products and inclusion of clients products in the PNDF, continuous improvement of product message in the product literatures and other promotional activities

Operations Excellence:

• Ensures that local medical, regulatory and promotional activities are in accordance with the PHAP and IFPMA Code of Pharmaceutical Marketing Practices, and ECLxe2x80x99s International Drug Promotion Code
• Advises our clients top management with regard to regular, special and ad-hoc training required for disease or product or marketing and sales and training management
• Conducts disease and product training to sales and marketing teams as necessary to elevate the level of professionalism of our clientxe2x80x99s sales and marketing team and thus differentiate them from competitors
• Ensures up to date knowledge base on therapeutic categories relevant to our clients portfolio
• Ensures personal growth and development by attending relevant pharmaceutical and medical society meetings or trainings
• Attends corporate training local or abroad for product and regulatory updates

Should you meet the above requirements, we urge you to apply by forwarding your CV along with any supporting documents to lynne@glass-house.co.za