Some opportunities happen only once in a lifetime – like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
The Clinical Supply Intern will be a contributor to achieve Alexion’s clinical and corporate goals. The Clinical Supply Intern collaborates with stake holders in developing the clinical supply plans and managing activities to deliver clinical trial supply. This role will cooperate with internal and external partners in compliance with regulations, internal procedures and GxP requirements. This role will be central in delivering complex clinical studies, and critical functions such as packaging, developing label strategies and defining the logistics strategy for global trials. This position will closely interface with Clinical Operations, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure Clinical material is available as required to achieve clinical trial strategy and timelines.
You will be responsible for:
Clinical Supply Chain Management
- Support and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials.
- Support the planning, creation and maintenance of IMP supply project plans, based on study forecasts with Clinical and Medical project managers and contract providers.
- Ensures that key supply project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.
- Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects.
- Provide clinical pharmacy input to study protocols and pharmacy manuals regarding preparation, administration, and dosing of IMP products.
General Responsibilities
- Collaborate with CSMs on generation and maintenance of GCS operations-related documents for all active and upcoming studies (list below)
- Ensure accuracy and completeness of GCS study documents in team storage space (BOX and Sharepoint) by performing regular filing, review, and organization of controlled documents
- Assist CSMs in managing document review and approval in DocuSign/ Adobe e-Sign
- Interface with external vendors (Almac, Catalent, PCI, Endpoint, etc) to obtain and maintain GCS study documents generated in day-to-day GCS operations
- Streamline process for document storage and archiving across GCS studies by identifying and driving areas of improvement
Regulatory Inspection Readiness Support
- Support CSMs during audit and inspection activities by compiling and requesting study documents in anticipation of auditor/inspectors’ requests
- Typically documents not already in BOX study folders
- Collaborate with TMF specialist to ensure all TMF filings are accurate and contemporized for all GCS studies, particularly ahead of study audits and inspections
- Assist CSMs with Storyboard creation and maintenance via communicating with involved functions and reviewing related study documents and/or TrackWise reports
You will need to have:
- Currently enrolled in an Undergraduate or Graduate program at an accredited Institution.
- Ability to communicate and maintain collaborative relationships
- effectively with key internal and external stakeholders.
- Ability to manage external vendors to achieve results.
- Some Knowledge and understanding of cGMP, ICH/cGxP guidelines and global Health Authority requirements.
- Proficiency in computer software applicable to IVRS/IWRS, Excel, Power point and MS Project.
- Good organizational, communication and presentation skills, effective project and time management skills and the ability to work under pressure.
We would prefer for you to have:
- Prior working or Volunteer experience
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion’s COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, click here.
