Primary Location - USA-WV-Morgantown
Organization - Mylan Inc.
Associate Manager, Regulatory Operations - 18001895
For Us, It's A Mission
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.
Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:
Gather project details from varied internal and external sources and effectively communicate all details to the internal team and senior management in an organized and strategic manner.
Leads the creation and tracking of project management plans that clearly define the project scope, assumptions, risks and overall project approach including project resource needs, high level timelines, and project communications.
Develop detailed process maps and business requirements for various global regulatory activities.
Identify process gaps, best practices, and internal opportunities for increased efficiencies and standardization.
Collaborate with Regulatory Affairs personnel to socialize proposed changes and ensure input from all stakeholders.
Assist with the development and implementation of procedures and training for new and revised processes.
Contribute to the continuous improvement of existing department processes and strategies.
Serve as a central resource for Regulatory Reference Materials in the Document Management System (Documentum/D2) to include responding to questions, providing support, acting as coordinator, and managing other system-related information.
Engage and manage resources to meet project timelines.
Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:
Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration.
Must possess solid experience within the Pharmaceutical industry. Must have knowledge of Regulatory requirements and expectations
Must possess ability to multi-task and manage multiple projects and deadlines. Ability to work in a highly cross functional team environment. Must possess very good attention to detail and propensity to learn. Must be proficient in Microsoft Word and Excel.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.
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.
Normal office situation.
Proficiency in speaking, comprehending, reading and writing English is required.
Mylan 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.
If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.
Schedule - Full-time
Job Posting - Dec 5, 2018, 7:09:57 PM
Unposting Date - Ongoing