3849 Viatris Specialty LLC
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:
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
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Access – Providing high quality trusted medicines regardless of geography or circumstance;
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Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
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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 Senior Documentation Specialist GRA Brands CMC role will make an impact:
Key responsibilities for this role include:
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Applies required Submission Readiness document formatting to authored CMC content per Viatris’ Global Submission Standards.
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Manages and prioritizes all workload according to CMC SPA (Submission Planning Application) planned handover dates.
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Articulates issues for resolution, communicating regularly with stakeholders to ensure alignment.
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Supports CMC/Author Strategists and Team Leads with any number of tasks, including, but not limited to.
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Development and management of SPA project and submission plans.
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Development and management of Submission Content Plans (SCPs).
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Management and update of CMC CTD templates.
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Management of Product Dossier Manager (PDM) document replacement activities.
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Creation and management of Product Change Forms (PCF) within the PDM system for certain non-complex CMC lifecycle maintenance changes (ex. annual reports, renewals, license withdrawals & divestitures) & management of related activity scheduling activities.
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Limited CMC submission authoring.
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Coordination and/or support to ancillary document requests and management.
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Assisting with CMC change management projects to enable PDM baselining (retrospective PDM updates).
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Preparation and communication of metrics to track CMC submission volumes, reworks, health authority queries and associated trends, CMC commitment timelines & progress, etc.
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Develops and maintains effective relationships with local and global internal partners, i.e., CMC Product Leads; R&D; Quality; Global, Country & Regional Regulatory Leads, and Regulatory Operations.
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Completes training-related activities (e.g. compliance-related, HR policies) and individual development plans in adherence of required timelines, participates in cross-disciplinary forums and learning opportunities, engages in Straight Talk and Listen exchanges, demonstrates and models adherence to all Viatris’ behaviors and values, embraces and complies with Principles of Integrity.
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Performs other duties as assigned.
The minimum qualifications for this role are:
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Bachelor's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration. The ideal candidate will have an educational background and experience in Regulatory, Quality, or other technical discipline, including IT.
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Must possess general knowledge of Global regulatory submissions and publishing requirements.
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cGMP and compliance requirements.
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Accuracy and attention to detail.
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Ability to respond quickly to changes in priorities.
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ICH CTD (Common Technical Document) requirements.
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Excellent written & oral communications.
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Computer literacy with Microsoft Office Suite and Documentum-based applications.
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Position functions autonomously, however, will take direction from a large number of CMC Author/Strategists, CMC Product Leads and/or Team Leads. An ability to prioritize requests and negotiate realistic timelines is essential to succeeding in this position.
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Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
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Proficiency in speaking, comprehending, reading and writing English are preferred.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $54,000.00 – $101,000.00 USD.
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.
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