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Job Title: Team Leader / Sr. Team Leader - Global Labeling COE (Core Labeling Strategy) Location: Hyderabad
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how this role holder will make an impact.
Role Purpose Provide regulatory labelling leadership, governance, and expertise to Viatris products such that the Product Information texts (labelling) of existing and new products are successfully maintained globally. In this role the individual will have responsibility for the creation, development, and maintenance of compliant Core Labelling documents including Global Ad Promo and Medical Marketing review and approval, in alignment with Viatris principles and procedures.
Key responsibilities Accountable for management of the labelling process and labelling development. Leads preparation, review and approval of global labelling documentation (e.g. CCDS, Core Patient Information) as well as territorial labelling documentation (e.g. Common EU SmPC’s and USPI’s) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies. Leads labelling strategy in partnership with Global Regulatory in line with the overall regulatory Strategy by providing labelling expertise (labelling regulations, internal processes, and impact analysis of competitor profiles) for CCDS, USPI (including Abbreviated New Drugs Applications, New Drug Applications and Biologics License Applications) and group managed EU SmPC’s (Centralized / Mutual Recognition / Decentralized Procedures) as well as abbreviated PIs thereof. Establishes close partnership of labelling leads with project leads and the regulatory matrix to ensure effective, strategic, and proactive labelling development. Interfaces directly with senior management, functional experts, on business strategy and labelling content. Works closely with the aligned Regulatory Strategist and any other stakeholder teams as needed to lead all labelling aspects for the defined portfolio. Leads labelling updates and development, critically evaluating the data and principles upon which labelling statements are based to ensure clinical relevance and regulatory acceptance across the portfolio. Working with Global Product Safety and Risk Management – Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Global Labelling Committee (GLC) for endorsement of recommendations. Commercially astute, with a strong understanding of competitor labels and evolving external labelling trends and agency requirements Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously and employs sound judgment in solving complex problems Internally, influences key proposed guidelines and regulations to shape external environment May be active in external facing activities and is effective at representing Viatris in various industry groups (such as e.g., DIA, Navitas, trade associations) or at EMA (European Medicines Agency)- or FDA-sponsored events (e.g., Workshops, Ad Coms)
Knowledge, Skills, Qualification & Experience KNOWLEDGE Regulatory experience including in-depth Labelling knowledge. Understand GLC requirements/ processes and EU/ US regulatory requirements
SKILLS AND ABILITIES Highly developed interpersonal, presentation and communication skills. Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations. The ability to influence effectively in a matrixed, cross-functional team environment
EDUCATION/EXPERIENCE Minimum of a Bachelor's degree (or equivalent) in Science, Medicine or Pharmacy, or another related field with 7-10 years of experience and 5 or more years of Labelling and Labelling development experience. Preferred candidate will Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy. However, a combination of experience and/or education will be taken into consideration.
LANGUAGE SKILLS Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
MATHEMATICAL SKILLS Ability to perform computations such as percentages, ratios, and rates.
REASONING ABILITY Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how this role holder will make an impact.
Role Purpose Provide regulatory labelling leadership, governance, and expertise to Viatris products such that the Product Information texts (labelling) of existing and new products are successfully maintained globally. In this role the individual will have responsibility for the creation, development, and maintenance of compliant Core Labelling documents including Global Ad Promo and Medical Marketing review and approval, in alignment with Viatris principles and procedures.
Key responsibilities Accountable for management of the labelling process and labelling development. Leads preparation, review and approval of global labelling documentation (e.g. CCDS, Core Patient Information) as well as territorial labelling documentation (e.g. Common EU SmPC’s and USPI’s) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies. Leads labelling strategy in partnership with Global Regulatory in line with the overall regulatory Strategy by providing labelling expertise (labelling regulations, internal processes, and impact analysis of competitor profiles) for CCDS, USPI (including Abbreviated New Drugs Applications, New Drug Applications and Biologics License Applications) and group managed EU SmPC’s (Centralized / Mutual Recognition / Decentralized Procedures) as well as abbreviated PIs thereof. Establishes close partnership of labelling leads with project leads and the regulatory matrix to ensure effective, strategic, and proactive labelling development. Interfaces directly with senior management, functional experts, on business strategy and labelling content. Works closely with the aligned Regulatory Strategist and any other stakeholder teams as needed to lead all labelling aspects for the defined portfolio. Leads labelling updates and development, critically evaluating the data and principles upon which labelling statements are based to ensure clinical relevance and regulatory acceptance across the portfolio. Working with Global Product Safety and Risk Management – Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Global Labelling Committee (GLC) for endorsement of recommendations. Commercially astute, with a strong understanding of competitor labels and evolving external labelling trends and agency requirements Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously and employs sound judgment in solving complex problems Internally, influences key proposed guidelines and regulations to shape external environment May be active in external facing activities and is effective at representing Viatris in various industry groups (such as e.g., DIA, Navitas, trade associations) or at EMA (European Medicines Agency)- or FDA-sponsored events (e.g., Workshops, Ad Coms)
Knowledge, Skills, Qualification & Experience KNOWLEDGE Regulatory experience including in-depth Labelling knowledge. Understand GLC requirements/ processes and EU/ US regulatory requirements
SKILLS AND ABILITIES Highly developed interpersonal, presentation and communication skills. Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations. The ability to influence effectively in a matrixed, cross-functional team environment
EDUCATION/EXPERIENCE Minimum of a Bachelor's degree (or equivalent) in Science, Medicine or Pharmacy, or another related field with 7-10 years of experience and 5 or more years of Labelling and Labelling development experience. Preferred candidate will Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy. However, a combination of experience and/or education will be taken into consideration.
LANGUAGE SKILLS Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
MATHEMATICAL SKILLS Ability to perform computations such as percentages, ratios, and rates.
REASONING ABILITY Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.