Shire Regulatory PLS Manager in Cambridge, Massachusetts
The PLS Submissions Manager is responsible for vendor management of outsourcing of US FDA 2253 Advertising and Promotional submissions, including process development and improvement and key metric tracking. They are also responsible for the planning, publishing (paper, NeES, eCTD), review and dispatch of regulatory compliance submissions to global Health Authorities within required timeframes as well as maintenance of the global registration tracking tool with a focus on US Form 2253 Advertising and Promotional Submissions. They also represent Global Regulatory Operations in special initiatives, process design and validation testing of new and upgraded software.
Develop the submission model for outsourcing of US From 2253 Ad Promo submission and developing process and ensuring continuous process improvement of the established model. Managing relationship and transfer of work between Shire and third parties for the planning, publishing and review and dispatch of US Form 2253 Ad Promo regulatory compliance submissions, including compliance with agreed upon metrics and ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
Collaborate with GRO submission teams to have oversight to and ensure the submission portfolio is properly supported with an emphasis on FDA Form 2253 Ad Promo submission, with in-house publishing team. Work with internal and external stakeholders to ensure business needs are met. Stay current with new electronic submission and regulatory documentation practices issued from global health authorities; Propose new regional and global processes for paper and electronic submission publishing, including the evaluation of current processes; Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites
Contribute to new and updated processes and standards; Participate in validation testing of new and upgraded software; Responsible for the accuracy of information for submission metrics and registration information for senior management; Participate in GRA special initiatives.
Education and Experience:
Bachelor's degree is required. Scientific and/or computer science field preferred.
5+ years of pharmaceutical experience in a global regulatory environment, with preference for expereince managing external vendor in outsourced submission model. Experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.).
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.