- Merck & Co. (North Wales, PA)
- …Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory ... 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end ...Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on… more
- Larimar Therapeutics (Philadelphia, PA)
- … regulatory strategies. Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions Experience ... Affairs will be a key member of the regulatory , clinical project, and technical operations (cross-functional) teams who will manage CMC regulatory … more
- Eisai, Inc (Philadelphia, PA)
- …vendor management, and technical oversight to support the objectives of Global Regulatory Operations . The Associate Director will collaborate with the Heads ... the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final… more
- Merck & Co. (Montgomery County, PA)
- …campaign(s) and collaborating across multiple stakeholders (including sales, marketing operations , Legal, Regulatory , Medicals, etc.) to drive promotional ... vendor selection, SOP development, budgeting, and launch readiness.Manage day-to-day operations of the patient support program, ensuring timely, high-quality patient… more
- Merck & Co. (Upper Gwynedd, PA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations )Provide ... Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations , Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory… more
- Aequor (Aliquippa, PA)
- …and operations . Prepare for and support internal and external regulatory inspections and audits. Lead the development, revision, and lifecycle management of ... brings several years of practical supply chain or warehouse operations experience, including receiving, documentation management, inbound/outbound coordination, and… more
- Merck & Co. (North Wales, PA)
- …value product solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and colleagues.As a Technical Product Manager ... within Business Operations Technology product line (supporting applications related to Workflows, Planning, Quality, Compliance, Vendor Management) you will spend a… more
- Merck & Co. (North Wales, PA)
- …creative campaigns and collaborate across multiple stakeholders including sales, marketing operations , Learning and Development, Legal, Regulatory , Medical, etc. ... They will develop and track key performance indicators (KPIs) to ensure success at key pre-launch and launch milestones. Key responsibilities for the HCP Strategy role include:- Lead physician strategy development and support the Director of HCP Strategy to… more
- Reed Smith LLP (Pittsburgh, PA)
- …structure make us the go-to partner for complex disputes, transactions and regulatory matters. Our team of 3,000 people (including more than 1,600 lawyers) ... and ensure alignment with firm standards, industry requirements, and regulatory expectations. Provide technical support and administration for LAN/WAN, remote… more
- Sanofi (Swiftwater, PA)
- …be the Manufacturing Systems & Automation Site Support interface with Operations personnel, QA Compliance, Information Systems, Engineering, Maintenance and the site ... data management. Deliverable Accountability: Ensure compliance with GMP and regulatory standards (C&Q), including user/functional/detailed specification development, test protocols,… more
