SGS_JOB_1037
Contract - 08 Months+
Performs eCTD submission management across Biogen's product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Ops. Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.
Location ; Houston TX. The Deviation Investigator/Initiator Level III is responsible for the initiation, investigation and completion of Minor and low/medium severity Major process deviations unassisted, and the supervised completion of high severity Major and Critical process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence
The Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities. Also participate in quality testing for customer in-process, final product testing, and stability studies when needed.
The role “Scientific Publication Manager –Global Scientific Communications/Publications, Oncology” reports into the Global Medical Oncology team that is part of the Medical Specialty Care organization serving as a supporting partner to the Publications Lead. This role will work cross-functionally with commercial, regulatory, clinical, and market access on therapeutic solutions to support patients’ needs. Within our Global Medical Oncology team, we are committed to advance transformative therapies to help improve outcomes and impact the lives of people living with many different types of cancer. Global Scientific Communications/Publications, Oncology.
We are seeking a Marketing Automation Support professional to assist our client with various activities related to Email Marketing Campaigns, Personalization Campaigns, and A/B Testing using Adobe Marketo. The ideal candidate will have extensive experience in B2B marketing automation and a strong understanding of database management.
The Equipment Validation Specialist IV plays a crucial role in ensuring that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This position provides scientifically sound documented evidence to Operations, Quality Assurance, and regulatory bodies that systems and processes will perform as required, supporting a quality, compliant manufacturing environment.
The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This role provides scientifically sound, documented evidence to Operations, Quality Assurance, and regulatory bodies, supporting a quality, compliant manufacturing environment.
The Analytical Validation Specialist III role focuses on supporting validation activities for analytical systems, such as software updates, new system introductions, and system decommissioning. This individual collaborates closely with senior specialists and other teams to ensure high-quality performance and compliance with industry standards. The role involves troubleshooting, executing qualifications, and supporting system changes while ensuring data integrity and quality systems adherence.
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