Shire Regulatory Technologies and Information Management Support in Cambridge, Massachusetts
The Global Regulatory Technology and IM Support will further the vision for Global Regulatory Affairs (GRA) in alignment with Shire’s business model to establish and support Shire’s global approach for Regulatory technologies and Regulatory information management. This position will provide global support to the Regulatory Affairs and Regulatory Operations organizations for GRA systems and collaborate with the respective R&D Information Technology staff.
· Using the company ticketing system provides day to day ‘How to’ ticket support for Global users in the GRA Application systems and tools that manage R&D Submissions and Registrations.
· In partnership with R&D IT will assist in resolving technical issues with the GRA Application systems and tools by replicating user issues and carrying out some basic troubleshooting steps.
· In partnership with R&D IT will manage the user access on GRA Application systems and tools, Shared Information areas (internal and external) and Shared drives.
Will participate in the development and maintenance of supporting information related to the use of GRA systems, e.g. system job aid/ help guide.
· Support the Project Leads during System upgrades and maintenance by executed User Acceptance Tests and participating in some adhoc system testing.
· Assist business users with UAT executions.
· Work with the Project Leads to support integration projects and the import of documents into the GRA Application systems.
· Work with the leads by assisting in gathering user requirements for new GRA Application systems.
Maintains up-to-date knowledge of new software releases, global standards and procedures for regulatory submissions, including eCTD, IDMP; Publishing standards and analyzes new and revised guidance, advises regulatory management of new requirements, and recommends course of action.
Education and Experience
Bachelor's degree or related experience is required. Scientific and/or computer science field preferred.
· Minimum of 1+ years of pharmaceutical experience in a R&D environment or (3+ years without a Bachelor degree)
· 1+ years’ experience in Business/Technical Support role
Knowledge of the requirements for electronic submissions to regulatory authorities. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. Documentum®, FirstDocs®,eCTDXpress, Validation tools) is highly preferred.
· International experience is desired.
· Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
· Excellent analytical and communication skills both verbal and written.
· A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach.
· Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
Strong technical and problem solving skills, with an ability to understand and translate business issues and requirements. Ability to work on complex projects and timelines in a matrix team environment.
· Strong attention to detail and accuracy is a must.
· Demonstrated ability to integrate planning efforts across departments to ensure organizational effectiveness.
· Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration; demonstrated ability to facilitate a beneficial resolution of conflict.
· Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to work in diverse teams to optimize decision-making.
· Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines. Familiarity with the drug development process.
· Strong interpersonal, managerial and organizational skills.
· Knowledge of process development methodologies
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.