Senior Medical Advisor

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization in developed and emerging markets.

Role: Sr Medical Advisor, Medical Affairs

Location- São Paulo, Brazil

We are seeking a candidate in Brazil Region as Medical Advisor within the Clinical Development and Medical Affairs organization. Reporting to the EM Head of Medical Affairs; the Medical Advisor will be involved in KOL engagement/ HCP interactions and provide Scientific support to KOLs /HCP to execute the core medico marketing strategies as well as support with Pharmacovigilance activities.

Responsibilities

• Build a network of key opinion leaders through enhanced scientific interfaces and best practices
• Engage and build robust relationships with HCPs, and KOLs on value, access, and pharmaco-economic areas, also seek advice on unmet needs for patients and other stakeholders
• Develop/validate appropriate scientific content for conferences, briefing meetings & other policy-related activities/initiatives
• Assist in the planning of new campaigns and launch activities
• Be a brand ambassador for Biocon Biologics and its products
• Safeguard patient benefit always through the application of relevant knowledge of science, regulations, and compliance in all initiatives undertaken by the organization
• Prepare educational material/ videos/ website content/ patient information leaflets in collaboration with the medical affairs Centre of Excellence and marketing for relevant therapies.
• Ideate evidence generation through IITs and registries in line with strategy, addressing concerns/feedback from the HCPs, patients, and other stakeholders
• Author publications/blogs/white papers related to the value and differentiation of our products
• Collaborate with the training team in updating and reviewing slide decks/manuals and other relevant materials
• Promote patient centricity within Biocon Biologics
• Provide valid scientific responses to all the medical queries from the customers regarding the products and therapy area involved
• Promote diversity & inclusion in clinical trials, and data and get involved in ESG objectives as it pertains to medical affairs
• Together with the global teams, formulate meaningful real-world evidence studies, and support clinical strategy and execution related to registration and post-registration clinical trials.
• "Responsible for local Pharmacovigilance communications for the Pharmacovigilance System of the Registration Holder of Medicament
• To have oversight of the Pharmacovigilance system of the PRH/MAH in terms of structure and performance and to ensure directly or through supervision that the system components and processes are in place.
• Thorough understanding of the safety profiles of the products under the responsibility of the Medication Registration Holder
• Reside in Brazilian territory and be available to attend PV-related requirements and inspections.
• Promote inclusions and suggestions in the Risk Management Plans and Periodic Benefit-Risk Assessment Reports
• Ensure adequate and timely submission of expedited adverse reaction reports, PBRERs and other safety reports to the regulatory agencies as per applicable local regulations.
• To have oversight on weekly literature searches and to report the valid ICSRs to the regulatory agency in the territory as per the applicable regulations.
• To alert the Authority of any emerging safety issue(s) involving registered products. "

Other basic requirements include:

• Ability to interact with senior internal and external personnel
• Attention to detail and taking accountability
• Ability to work across more than a few therapy areas
• Create sense of purpose and inspiration in the team
• Must be able to work in a team environment, working closely with cross-functional teams
• Collaborate with medical affairs colleagues in other countries/regions and share knowledge and learnings
• Functional expertise in MS office, Veeva Vault
• Substantial knowledge and understanding of policies, procedures, and guidelines relevant to medical affairs operations
• Substantial knowledge of HCP policies and regulations
• Proven understanding of the needs of individuals living with cancer and chronic diseases like diabetes or other autoimmune diseases as well as pressing public health issues, including at the pharmacy and HCP levels.

Qualifications

• Bachelor's degree required; advanced degree preferred (e.g., MS, Pharm D, Ph.D., or MD);
• Minimum 05 years of medical affairs, patient access, and advocacy experience in the biopharmaceutical, or relevant non-profit or payer industry.
• Must be willing and able to travel (approximately 30%) regionally, including to other countries within the EM region.

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.