Head of Medical Affairs at Cipla

Job Purpose

• Develops and implements medical and scientific strategies to support Company objectives. Directs all medical activities and scientific activities within Cipla and ensures compliance with ethical and medico-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.

Accountabilities-1
Drive and shape the strategy and policy of Cipla Medical Affairs within the Organisation and also with relevant stakeholders within South Africa

• 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 team’s 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.

Accountabilities-2
Manage the Medical Affairs Team to drive the passion and commitment required to fulfill the objectives of the function

•  Ensure that values and leadership standards are communicated and understood across all levels.
•  Build trust among Team members and broader stakeholders by setting a highly visible example for colleagues within the Team in terms of professional excellence and commitment to demonstrating Cipla values and competencies.
•  Provide clear role responsibility, establishing a climate of continuous measurement and performance improvement.
•  Create processes to share information and experiences, leverage initiatives across the function where appropriate, and enhance productivity of Medical Affairs efforts for the Cipla brand.
•  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.

Accountabilities-3
Manage Reactive Medical Affairs by addressing medical queries professionally and on time

• Ensure that all medical activities are conducted in accordance with local and corporate policies, whilst complying with national legal requirements and guidelines so as to maintain Cipla’s position, image and credibility and in order to improve and support its business in the country.
• Assure high medical quality and corporate ethical integrity.
• Manage all medical information services to ensure that all activities are conducted in accordance with national legal requirements and guidelines and corporate policy.
• 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 that requires the information. Ensure that the systems for medical information are streamlined, e.g. standard procedures, prepared communication for commonly asked questions.
• Ensure that the Medical Affairs function is capable of handling drug safety, reviewing individual adverse event reports, aggregate adverse event statistics, and on a needs be basis liaising with customers about drug safety

Accountabilities-4
Managing Proactive Medical Affairs by providing the right information to the right people at the right time.

•   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 Cipla drugs.
•   Participate in the strengthening of Company image toward the scientific community, health authorities, regulatory bodies and industry associations.
•   Identify future Medical opportunities and capabilities through thorough on-going analysis and reviews.
•   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.
•   Develop engagement plans and establish ongoing liaisons with key opinion leaders, government officials, and healthcare organisations and ensure that significant developments in the field are identified and monitored.
•   Ensure the liaison and cross-collaboration of Medical Affairs with Regulatory, Commercial, Business Development and the Project Management Office.
•   Ensure that scientific input and expertise is incorporated in the design and construction of all promotional materials and events. Ensuring that materials are reviewed for scientific accuracy and legal/regulatory compliance.
•   Perform Health Hazard Assessment (HHA) when required

Accountabilities-5
Medico-Marketing function

• Act as the Cipla voice for all Medico-Marketing functions.
• Manage and facilitate local and global Medico-Marketing opportunities.
• Advise and guide marketing teams on the appropriate marketing strategies based on sound medical and scientific rationale.
• Provide key Medico-Marketing input and solutions to support the resolution of business challenges.
• Ensure the active contribution of medical affairs to the revenue and sustainability of Cipla through tangible short, medium and long term targets, and ensure that leadership has a shared perception and understanding of the importance and criticality of the medical affairs contribution.
• Create and maintain a collaborative team culture that values, recognizes and generates high performance, supports innovation, challenges the status quo and actively participates cross-functionally.
• Provide clear role responsibility, establishing a climate of continuous measurement and performance improvement.
• Create processes to share information and experiences, leverage initiatives across the function where appropriate, and enhance productivity of marketing efforts for the brand
• Provide functional feedback on how well Medico-Marketing is meeting the needs of the business and delivering a quality service in areas of priority.
• Actively support development of direct reports and high-potential colleagues within and across the Team, providing insights, direction and opportunities.
• Accountable for ensuring that all Medico-Marketing staff members have clear accountabilities and are clear on priorities.
• Regularly interact with Commercial Executive Director to ensure Medico-Marketing meets the needs of the business.
• Be the custodian of ethical marketing practices within the organisation by ensuring that relevant standard operating procedures are in place, training is conducted, and procedures are adhered to; and ensuring that appropriate approval processes are in place.
• Ensuring there is appropriate segregation of duties and authority between medical and marketing to ensure compliance to the relevant requirements of promotional and scientific activities.
   

Accountabilities-6
Medical Affairs

• Develop, control and shape strategies for assigned 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 Cipla brand.
• Provide medical support to the Commercial (Marketing and Sales) team with relevant information to contribute to the execution of the commercial strategy to achieve business objectives for SA
• Support to the training department.
• Support to Regulatory Affairs
• Support the development of a robust portfolio by identifying gaps and understanding and keeping abreast of the changing therapy landscape, to have an appropriate product mix and pipeline for the company
• Develop and manage internal and external stakeholder and cross-functional relationship to ensure medical support and provide value to the business
• New Business Support
• Reimbursement motivations when required
• Review & Approve:
  •          Educational material
  •          Marketing material (e-detailers)
  •          Medinformer Patient Booklets
  •          Non-promotional material
  •          Patient information brochures
  •          Promotional material
  •          PSP material
  •          Training material
  •          Marketing material (leave behinds)
  •          Corporate Communication
• Social/Media:
  •           PR campaigns
  •           Blog content
  •           Public relations statements review
  •           Press releases review & approval
  •           Responses to competitor pressure/influence
  •           Scripts for radio/TV
  •          Website content material generation
  •          Website content material
• Initiate and conduct scientific advisory board meetings when needed. Provide medical and strategic input, conduct the scientific meetings, and gain insights from KOLs

Accountabilities-7
Pharmacovigilance

•   Oversee and manage the drug safety officer and drug safety activities and essential related tasks for Cipla 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

Accountabilities-8
Medical Financial Management

•   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

Accountabilities-9
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

Key Opinion Leaders ( KOLs) and other associations :

•  Identify and select new KOLs specific to therapy areas for potential relationship building
•  Develop and enhance new and existing KOL relationships through involvement on various scientific activities conducted by the company such as advisory board, medical educational program etc.
•  Interact with the KOLs on a regular basis to keep updated about the latest trends and market expectations in the assigned therapy areas
•  Develop and maintain contacts with key opinion leaders (local and international), clinical investigators, policy makers and all potential stakeholders that influence the business
•  Collaborate with key medical institutes and professional societies
•  Build and strengthen the company image and business opportunities by interacting with the scientific community, health authorities, regulatory bodies and industry associations. Engage with the health care funders on a health and pharmacoeconomic level to assist company to have marketed products formulary referenced

Engagement and Conference attendance in order to upskill on the relevant product knowledge and to aid in improving the service that can be provided. Examples below (but not limited to) :

•  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

Education Qualification

• Medical Doctor

Relevant Work Experience

• Minimum 8 years of experience in Medical in the Pharmaceutical Industry and hands-on experience in Medical Affairs