Job Description

Division

Regulatory Affairs

Department

Medical Affairs

Employment Type

Permanent

Job Purpose

Generate and provide scientific know-how in designing promotional strategies, supporting sales force development, regulatory, pharmacovigilance, training, compliance/ethics, and other scientific communications, in order to shape the assigned therapy(s) in an ethical and medically accurate approach.

Accountabilities - 1 and 2

i. Achieve scientific proficiency to drive the development of assigned therapy areas in accordance with the medical strateg:

• Keep abreast with the latest medical developments through publications, websites and by attending national & international conferences.
• Understand on ground clinical practices by interacting with clinicians, to develop practical knowledge and utilize it to provide closer-to-market product solutions.
• Create scientific information on key therapeutic areas for Medical Information Database.
• Identify the need, plan for, and assist in selecting faculty, for organizing advisory boards, CMEs, journal clubs, symposia, webcasts, conferences etc.

ii. Ideate and conceptualize with marketing team to develop promotional strategies to drive South Africa bussiness:

• Contribute to and curate scientific content for promotional material (such as newsletters, scientific booklets etc.) for online and offline usage by the marketing team during campaigns.
• Review medical literature.
• Create medical material to support new product launches.
• Share latest product and therapy developments in the market, with the marketing team.
• Develop medical content to support patient engagement for the product.
• Provide medical resources (such as published data) to equip the field force with accurate content to tackle doctor queries

Accountabilities - 3, 4 and 5

iii. Training:

• Develop content and material for medical trainings of internal teams.
• Evaluate and review all training material.
• Train new and existing sales representatives to build capacity by providing a deeper understanding of the disease entity / therapeutic area.
• Deliver SOP training to the marketing team with regards to Medical Affairs relevant SOPs.

iv. Build external advisor relationship to help steer the therapy market:

• Identify new KOLs and initiate contact with them.
• Engage existing and new KOLs through various scientific activities.
• Engage with marketing related agencies

v. Ensure ethical actions by adhering to regulations and laws:

• Ensure compliance and adhere to internal policies, local and international regulations for scientific, promotional materials, activities and therapy / product related queries from internal and external stakeholders.
• Review professional information of products as per the latest regulatory requirements.
• Review SOPs and guidelines

Accountabilities - 6 and 7

vi. Business Support:

• Guide, review and approve all marketing, educational, corporate communication and training material in accordance with applicable laws, regulations and internal procedures.
• Drafting and reviewing SOPs
• Medical and scientific support for new products
• Liaising with cross-functional partners

vii. Provide support to Regulatory Affairs and Quality Assurance:

• Provide the scientific input required to ensure dossier submission.
• Provide the scientific input for appropriate responses to regulator queries raised.
• Provide guidance for regulator-related communication e.g medical review of updated professional information.
• Develop Professional Information and Patient Information Leaflets for new products.

Accountabilities - 8 and 9

viii. Conceptualizing marketing strategy:

• Liaising with brand teams
• Liaising with agencies
• Close working with commercial team in the field
• Inclusion in commercial meetings

ix. Complementary medicines:

• SOP development and training.
• Provide scientific and medical input required to ensure professional information creation.
• Develop professional information and patient information leaflets.
• Liaise with cross-functional business partners.
• Liaise with external manufacturers.
• Initiate all artwork components.

Education Qualification

MPharm, Masterxe2x80x99s in Biological Sciences / Pharmacy / PhD/ MBBS/ MD/ MBChB

Relevant Work Experience

• Minimum 2 yearsxe2x80x99 experience for Masterxe2x80x99s in Biological Sciences / Pharmacy
• 0-2 yearsxe2x80x99 experience with PhD/ MBBS/ MD

Competencies/Skills

Perform with Accountability
Lead with Empathy
Act with Agility
Innovate to Excel
People Management
Collaborate to Succeed
Strong Domain Knowledge

Job Location

Head Office (Cape Town - Bellville)

EE Requirement

Cipla is an Employment Equity employer and this position will be filled based on our Employment Equity Plan.