Director, Inspection Readiness and Clinical Oversight

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; 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 the Director, Inspection Readiness and Clinical Oversight role will make an impact:

Key responsibilities for this role include:

• Accountable for the development, implementation, and maintenance of departmental and program level inspection readiness strategy.

• Collaborate across Viatris and other related regulatory/quality functional areas to ensure that departmental and program level risks are minimized.

• Support clinical operations and assist clinical investigators in preparation for regulatory agency inspection through conduct of mock inspection and training and participate in Clinical Operations sponsor and clinical investigator regulatory agency inspections.

• Accountable for the development, implementation, and maintenance o program and study level clinical oversight activities to help ensure tasks delegated to CROs are completed in compliance with SOWs, protocols, SOPs ICH/GCP, regulatory requirements and guidelines and Viatris Standards.

• Oversee and/or conduct oversight visits to CROs and clinical investigators.

• Collaborate across the clinical study teams to assist with the development of monitoring oversight plans and other applicable study plans.

• Provide in-depth guidance/understanding of ICH/GCP and SOPs to global clinical operations personnel and cross-function clinical study teams.

• Participate in development and review of Clinical Operations processes, systems, and initiatives.

The minimum qualifications for this role are:

• Minimum of a bachelor’s degree (or equivalent) and minimum of 8 years of clinical project management experience. Experience in organizational defense of submissions to regulatory authorities, such as SOPs, training records, etc. required. However, a combination of experience and/or education will be taken into consideration.

• Must possess in depth level of knowledge regarding global clinical trial operations, regulatory submissions, and dealing with regulatory agency audits and inspections. Expert level knowledge and interpretation of Regulatory Agency (e.g., FDA, EMA, MHRA, etc.) regulations and industry guidance documents, policies, and procedures pertaining to IND/NOA submission, approval, and post approval processes required. Must possess comprehensive knowledge of drug development, clinical trial management, and transfer of sponsor obligations.

• Must possess strong communication, organization, planning, analytical, and problem-solving skills. Demonstrated experience with working with the Microsoft suite of programs (Word, Excel, PowerPoint, Outlook). Good understanding of clinical trial related software (eCRFs, IWRS, CTMS, eTMF etc.).

• Must possess ability to travel up to 25%; however, dictated by the needs of assigned clinical program(s).

• 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.

• 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 perform computations such as percentages, ratios, and rates as well as perform statistical analysis. Ability to draw and interpret graphical data. Ability to understand pharmaceutical calculations is preferred.

• 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. Periodic travel is required. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements.

• Normal office situation.

• 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.

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.