- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (North Wales, PA)
- …clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- …of its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of ... in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Durham, NC)
- …vaccine manufacturing facility in Durham, North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, ... strong individual and has the ability to communicate effectively with senior management on complex technical issues and manage multiple high-priority, complex… more
- Twist BioScience (South San Francisco, CA)
- …the company's product and technology pipeline.Executive Engagement:Present strategic recommendations to senior leadership and the executive team; lead external ... Twist Bioscience is seeking a strategic and execution-oriented Director or Senior Director of Business Development (title commensurate with experience) to lead … more
- Merck & Co. (Rahway, NJ)
- …commercializing and supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head of Global ... multi-product launch manufacturing.To achieve this, this highly experienced leader will lead cross-functional launch readiness teams at each site, drive the… more
- Merck & Co. (North Wales, PA)
- …Global Regulatory Affairs.--The AVP provides leadership and direction through senior -level and first-line managers and statistical staff focused on end to end ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Merck & Co. (Rahway, NJ)
- …at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define ... group strategy and to lead a team of scientists in solving complex analytical...and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for… more
- Merck & Co. (Rahway, NJ)
- …Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics ... different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving… more
- Merck & Co. (Durham, NC)
- Job DescriptionJoin our dynamic Engineering, Maintenance, & Utility Department as a Senior Specialist, where you will play a crucial role in enhancing asset ... to focus instrument performance and minimize downtime.Initiate and complete SOP revisions. Lead 8-step problem solving sessions to support investigations and develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check… more
- Merck & Co. (North Wales, PA)
- …pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore requiring ... the pediatric section of the Vaccine Clinical Development TA.May serve as a senior therapeutic area content expert within the company, providing input into research… more
- Merck & Co. (Rahway, NJ)
- …& Manufacturing, in a fast-paced, multidisciplinary environment- - Participate in or lead 1) development of robust and scalable purification processes for biologics ... in different stages of clinical development, 2) process characterization and regulatory filings for successful commercialization - Advance downstream processes by… more
- Merck & Co. (North Wales, PA)
- …HTA/reimbursement agencies and health systems globally. The ability to participate and lead cross-functional teams is a critical part of this role.Types of studies ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
- Merck & Co. (Rahway, NJ)
- …development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, ... proven talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines,… more
- USAA (Phoenix, AZ)
- …experience leading aP&L and operating within best interest rule, state insurance regulatory licensing , approval, and regulatory requirements. Demonstrated ... relationships, leading the selection and management of sales, marketing, training, licensing , new business, service, money movement technology suppliers to operate… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- …CDER, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide regulatory guidance to R&, D, Technical Operations Sales ... and Patents issues and correspondences on both pending and approved applications. Lead , guide, and train the CMC team to ensure highly qualified personnel… more
