Shire Operations Lead, Nonclinical Development in Lexington, Massachusetts
Under the direction of the Head of NCD Operations, the Operations Manager assists with maintaining an efficient operating environment for Nonclinical Development (NCD) activities. The Operations Manager also assists in the efficient development, execution and filing of legal agreements, and related documents. The Operations Manager helps maintain the NCD contracts database, ensures electronic study- and project-related files are maintained to common standards, assists in the efficient management of study- and project-related accounts and assists the Head of NCD Operations in other activities as required.
Responsibilities (% of Time)
Develop a solid understanding of Shire’s processes relating to legal contracts
Liaise with the Legal department to progress legal agreements as required (Consulting Agreements, MSAs, CDAs, etc.)
Process all consulting engagements through Shire’s Compliance review system (RnD Select)
Request all contracts using on-line legal request form and process agreements through to execution
Ensure all legal documents are appropriately filed in electronic filing systems (PIMS and Axxerion, as appropriate)
Continually monitor status of legal agreements and initiate agreement renewal when required
Develop an understanding of Shire accounting practices relating to agreements, projects and studies
Raise POs for project-related spends
Set up all new project related vendors on SAP system and track in NCD’s internal systems
Work with Finance to resolve any project related invoice queries which come in for NCD
Responsible for tracking of NCD Resources:
Maintain online resource tracker for all project teams
Maintain a tracker for NCD resources utilized for BD and IIR projects
Lead quarterly tax credit exercise for NCD: compile and consolidate results, develop review materials and final submission
Budget and Long-Range Plan: support financial planning processes, forecasts and development of materials for internal review and submission to Finance
Develop an understanding of Shire’s SOP system
Assist with development of new departmental SOPs and Guidelines as appropriate
- Manage other ad-hoc projects/initiatives under the direction of the Head of NCD Operations, including those related to integration, compliance and/or other corporate activities
- Required: Bachelor’s degree in scientific discipline, or an understanding of R&D, plus minimum of 8 years of professional experience
Preferred qualifications include experience in biotech/pharmaceutical industry, especially in (or in direct support of) a nonclinical function
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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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.