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Shire Reg Product License Supp Sr. Specialist in Cambridge, Massachusetts
% of Time
Job Duty and Description
Primarily responsible for the planning and publishing of the GRO-managed submissions portfolio, with accountability of monitoring the submission forecast and ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
Maintain compliance for non-submission regulatory reporting on behalf of GRA, ensuring GRO is managing data according to agency requirements and internal processes (e.g. Pharmacovigilance Safety Master File, XEVMPD, Drug Establishment Information).
Maintain effective relationships with R&D contributing groups, ensuring timelines and requirements are mutually understood and in line with Shire and health authority standards.
Collaborate with GRO submission teams to ensure the submission portfolio is properly supported and work in a matrix environment to meet Shire’s business needs.
Interpret regulatory guidelines to produce regulatory submission business requirements and ensure that those requirements are implemented where appropriate at local level.
Operate as Subject Matter Expert in dossier types, processes and/or technical solutions, with responsibility for training and mentoring fellow colleagues.
Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites.
Review R&D documents to ensure compliance with Shire’s submission ready standards guidelines.
Contribute to new and updated process and standards.
Participate in validation testing and requirements gathering of new and upgraded software.
Responsible for the accuracy of information for submission-related metrics for senior management.
Participate in GRA special initiatives.
Education & Experience Requirements
Bachelor's degree is required. Scientific and/or computer science field preferred.
3-5 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.).
Key Skills and Competencies
Key Skills and Competencies
Proficiency in publishing paper, NeES, and eCTD submissions and using related tools.
Strong understanding of global regulatory requirements and the following submission types: Clinical Trial Listings, IND/NDA Annual Reports, IND Investigator Amendments, Safety Reports (Periodic and Aggregate), 2253 Ad/Promo submissions.
Knowledge of Structured Product Labeling (SPL) and Pharmacovigilance reporting.
Self-starter, who motivates, has tact, diplomacy, leadership skills and a flexible and positive approach.
Ability to identify and understand complex issues and propose creative and achievable solutions. Determines the causes and possible solutions to the problem.
Strong attention to detail and accuracy.
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization.
Ability to cultivate internal and external relationships.
Understanding of Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
Applicable knowledge of the drug development process.
Proficiency working in MS Windows environment and with Windows-based desktop productivity applications (MS Office) including Adobe Acrobat technology is required.
Internal and External Contacts
Internal (within GRA)
Global Regulatory Operations
External (across R&D)
Other Job Requirements
- Domestic and international travel may be required for this position.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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.