- Olympus Corporation of the Americas (Center Valley, PA)
- …. **Job Description** This role will primarily support iTind, an approved device for BPH. This role will be responsible for customer related engagement ... discussions with Olympus Health Economics & Market Access, Reimbursement in the development and review of reimbursement and economic materials and programs. May… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …by managing and maintaining study tackers and logs. + Manages device accountability for clinical studies, including tracking, shipment, and reconciliation of ... to ensure compliance with specified study protocols. + Oversee the design, development , and maintenance of clinical study tracking in the Project Plan Management… more
- Teleflex (Wyomissing, PA)
- …Molding Engineer will lead and coordinate the technical phases of process development in conjunction with manufacturing and new product development initiatives. ... package for the molding process. Assist with the identification and development of next generation processes related to plastics. **Principal Responsibilities** 1.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …strategy, and statistical methodology in support of proposal and protocol development . + Oversee contracted statistical service vendors and provide direction of ... or contribute to process improvement initiatives in biostatistics (methodology development , standardisation across studies, best practices). + Perform programming or… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …study coordinators on study requirements as applicable. + Assist in the development , review and implementation of processes, policies, SOPs and associated documents ... affecting CDM. + Support development and maintenance of CDM SOPs and training materials....+ Prior experience in a sponsor, CRO, or medical device company. In-depth knowledge and experience with FDA regulations… more
- Parexel (Harrisburg, PA)
- …regulatory strategy input for small molecules (previous experience with biologics and/or drug- device combination products are a plus) - Support regulatory leads in ... - Develop CMC strategies for products across all phases-from early development to marketing applications and post-approval changes Cross-Functional Collaboration -… more
- Inizio Engage (Bethlehem, PA)
- …If approved, people at risk for severe allergic reactions would have a device -free, needle-free epinephrine option. Similar in size to a postage stamp, Anaphylm is ... work to have genuine clinical impact. Key Responsibilities Strategic Territory Development Design and execute territory business plans that identify high-potential… more
- Olympus Corporation of the Americas (Breinigsville, PA)
- …at Olympus: https://www.olympusamerica.com/careers . **Job Description** As a medical device organization our Distribution Associates are critical to the receiving, ... + Ability to learn how to operate RF scanning device and other material handling equipment. + Ability to...Resource Groups + Dedicated Training Resources and Learning & Development Programs + Paid Educational Assistance *US Only **Center… more
- Organon & Co. (Plymouth Meeting, PA)
- …oversee non-clinical activities and safety assessments for Organon Research and Development (R&D) programs ranging from discovery through late-stage development . ... leadership position that includes management responsibilities of the non-clinical development scientists, who directly contribute to implementation and execution of… more
- Parexel (Harrisburg, PA)
- …judgement)), clinical trial, and literature cases including combination products {drug- device }) according to client/Parexel Standard Operating Procedures (SOPs; as ... (PSURs), Signal Evaluation Reports (SERs), Health Authority (HA) response documents, Development Safety Update Reports (DSURs), Clinical Overviews (COs), Addendum to… more
