Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
Sr Manager of Clinical Supply Operations is responsible for investigational material activities for Phase I-IV assigned studies within Mylan Clinical Operations, including coordination of packaging, labelling, and distribution at Contract Packaging Vendors.
This individual will collaborate with medical, regulatory, and clinical experts/personnel to ensure that quality Clinical Supplies are provided according to departmental SOPs and applicable regulations. This position also interacts with both internal and external supply chain and logistics personnel in the procurement of clinical drug supplies.
Every day, we rise to the challenge to make a difference and here’s how the Clinical Supply Operations Lead role will make an impact:
Serves as core team member for clinical projects representing investigational materials and/or technical operations.
Responsible for technical assessments, selection of contract packaging vendors to provide service for specific projects, review and approval of contracts, pack design, drug ordering, supply plan management for packaging and labelling activities conducted by clinical supply vendors and monitoring of budget.
Participates in audits and monitoring of clinical supplies vendors.
In conjunction with the clinical supply vendors and internal departments, coordinates QA/QP release of investigational materials to be used in global clinical trials.
Reviews and approves IVRS specifications from investigational materials perspective.
In conjunction with CRO and Regulatory, co-ordinates the design of clinical labels to meet protocol, FDA, EU and other country specific regulatory requirements.
Writes or reviews the Study Medication Sections of the protocol and IND as required.
In conjunction with clinical supply vendors, monitors Investigational Materials inventories and expiry/retest dates supplies.
Trains investigators and CROs on protocol procedures related to Investigational materials.
Creates, reviews, and revises Clinical Supply related SOPs as appropriate.
Perform other duties as assigned.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
Clinical Supplies knowledge with comprehensive operational experience in R&D Clinical Supplies and related areas on a global level. Must possess advanced knowledge of project management, packaging, labelling and distribution of clinical studies. Knowledge of and excellent understanding of Good Manufacturing Practice (GMP) and other associated regulations, guidelines, and industry standards for clinical trials.
Excellent interpersonal and communication skills
Strong planning, organizational, and problem-solving skills
B.S. Degree or related scientific discipline + 7 years pharmaceutical industry experience.
Thorough understanding of the development and clinical supplies process
Ability to maintain accurate records and files in accordance with GMPs, SOPs, and other regulatory requirements.
Experience with e-mail, Windows, word-processing, database, spreadsheet applications as well as Microsoft Project and PowerPoint
Strong decision-making, detail-oriented, multi-tasking, and negotiation skills
Ability to work effectively in a multifunctional team environment.
Be flexible.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris
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. Some of our benefits include the following on top of a competitive salary:
Top Employer Accreditation, demonstrating that we provide excellent people policies and practices
Competitive compensation package inclusive of annual discretionary bonus and stock options
Focus on career progression with growth and development opportunities
Emphasis on Health & Wellness programmes
100% paid medical insurance and Employee Assistance Programme
Life cover
Excellent employer-matched pension scheme with Viatris contributing up to 11%
2 paid volunteer days per year
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility
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.