SGS_JOB_1041
Contract - 04 Months only
This role is to fill in for 4 months for a Clients’ Manager who is going on a Maternity leave. Minimum of 5 years of relevant experience Proven experience with regulatory submissions, including IND and CTAs Strong background in reviewing and editing regulatory affairs documents At least a Bachelor’s degree (with a heavy emphasis on hands-on experience) Additionally, the position will involve a panel interview as part of the selection process We are seeking a Manager, Global Regulatory Affairs, to work closely with the Global Regulatory Lead (GRL) for a given program(s).
Responsible for overseeing the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology group. Reports to the Medical Lead for the given program(s) and is accountable for defining the strategy and execution of assigned trials. Clinical team leader with clear understanding of areas of responsibilities and accountabilities of the role. Team player who is comfortable in situations where the role serves as a consultant and supports other functions and particularly the asset area. Understands the criticality of information and knowledge management, partnership and collaboration required in drug development.
The successful candidate will join Development Support at Client, focusing on providing a variety on non-GMP services to internal Client’s customers throughout the PO&T organization. These services include basic and complex solution preparation, media and buffer characterization, definition of assay release criteria, and deviation investigation/troubleshooting.
M-F, 8am - 5pm. Full time, No OT... 100% Remote, Needed for at least one year, high possibility to extend for the full two years, No specific area/degree but must have a Bachelors Degree minimum... Candidate must be willing to participate/lead meetings and team calls occasionally. Manager values a candidate that is highly driven to learn to skills and take on new projects voluntarily. Manager likes candidates that are inquisitive. Need someone who is HIGHLY analytical. They'll be searching various systems, if they see something wrong they'll need to "go down the rabbit hole" to find out "why?" Need strong critical thinking skills to know when to search system to system for various bits of info. Must have experience working with multiple large data management systems, contracts and pricing, and/or contract development and analytics. Must have very strong writing/grammar and communication skills. Needs to have high attention to detail and accuracy. Interviews will be one with manager and then a panel interview. Must be able to perform high level Excel functions, formulas, vlook-ups. BONUS - manager would like to see Excel test scores.
Location: Exton PA 19341 (Hybrid; 2-3 days per week in office) Technical Writer, Analytical Outsourcing, Biopharmaceutical Development • Required proficiency in configuration, creating methods, reports, and custom calculations. • While not required, it would be a plus if this person had experience with validation of custom fields
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.
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