Reference #: R5651698
Mylan Inc.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; andPartnership - 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 role will make an impact:Key responsibilities for this role include:Serve as an active member for multi-disciplinary project teams as a nonclinical safety functional area subject matter expert.Articulate and communicate non-clinical safety strategies and provide development plans for multiple drug modalities including but not limited to small molecules, biologics, ADCs, and/or cell/gene therapies in multiple therapeutic areas and indications.Liaise with Non Clinical Operations as an active participant in the placement and conduct of nonclinical studies.Participate in due diligence reviews of drug products to identify potential risks and provide recommendations for partnership or in-licensing.Author, review, and submit regulatory documents (IBs, INDs/CTAs, NDAs/BLAs, and other regulatory correspondence), and interact with regulatory agencies (US and ex-US).Generate impurity, excipient, and metabolite risk assessments as necessary.Performs and serves as a reviewer on toxicological risk assessments for various health-based exposure limits (HBELs), such as ADEs, PDEs, ADIs and OELs. Perform and serve as a reviewer of environmental risk assessments (ERAs) and oversee the conduction of environmental studies to support such assessments.Support and mentor others regarding drug development and the execution of the portfolio, with an emphasis on non-clinical aspects.The minimum qualifications for this role are:Minimum of a master's degree (or equivalent) and 10 years of experience. However, a combination of experience and/or education will be taken into consideration. Preferred candidates must possess an earned doctoral degree in Toxicology, Pharmacology or related field and 6 + years of experience in toxicology/pharmacology.Must possess knowledge of the biological impact of drug product materials (APIs, excipients, impurities, etc.) in the human body.Demonstrated knowledge of global regulatory requirements and expectations and application of GLP and ISO, ICH and other applicable global guidelines for nonclinical safety assessment packages to support IND/NDA/ANDA submission. Demonstrated successful achievements in the previous positions.Must possess effective oral and written communication, organizational and computer skills. Must be able to interact with a diverse workgroup in a team-oriented environment with the ability to communicate performance expectations in a clear and concise manner.Proactive team player, excellent time management, problems solving skills, and flexibility to work on multiple projects as the programs evolve over time.Position functions semi-autonomously. Position may directly supervise employees. Must carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.English 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.Ability to solve equations, apply technical mathematical concepts, and perform complex computations.Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.Typically sitting at a desk or table. Intermittently sitting, standing, walking, or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements. Periodic travel is required.Normal office or work remote situation. Some travel, up to 20%, is expected.Proficiency in speaking, comprehending, reading and writing English is required.Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000 - $236,000.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.#LI-RemoteMylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â
