SUMMARY OF POSITION The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development progr...
Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations Serve as primary Sponsor contact for operational proje...
SUMMARY OF POSITION Independently authors, compiles, reviews, schedules, and submits high-quality regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements within company t...
Requirements: · Lead and execute long-form copy development for one or more brand engagements across HCP & Consumer audiences in the pharmaceutical marketing sector know, like the back of your hand, all aspects of the brand and disease st...
Notes: Candidate needs to be an individual or an independent contributor. Candidates from a complete CRO and FSP background are eligible. The Senior Clinical Data Manager (CDM) leads and coordinates Data Management (DM) deliverables from ...
Provide lead statistical programming support in the project specific programming of CDISC datasets (SDTM, ADaM), analysis outputs (tables, listings, figures), and ad hoc reports of all complexities. Provide leadership in project management ...
Location: Princeton, New Jersey Responsibilities Include, But Are Not Limited To · Onboarding and offboarding of employees · Conduct employee evaluations and implement performance plans · Employee relations- including investigations...
SUMMARY OF POSITION Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA w...