- Tris Pharma (Monmouth Junction, NJ)
- …assessment/conceptualization, development , design, specification, testing and implementation of packaging concepts. She/he assists and/or leads package trial ... for an experienced Packaging Component Engineer. The Packaging Component Engineer supports development , qualification and... or related science field and minimum 5 years package engineering, package development and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical trials requiring Clinical ... identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites for GMP processing operations. This position will work with a label… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages ... PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all...internal and external labeling guidelines, reviewing US and EU package inserts for assigned products with regard to both… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) ... global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communication with CSO project Management LeadResponsible for the Clinical Label Development process which includes creation of master label text, translations, and ... label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …selecting vendors. This position also supports the management of the WO development and implementation.Supports packaging design and patient kit supply ... on a Project basis.Vendor Management - support interactions with Vendors on packaging design and patient kit supply preparation, label generations and approvals.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical ... strategy, perform integrated analysis of efficacy and safety, generate submission data package , create TLFs to support submission QAs, perform ad-hoc and exploratory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical programming vendor ... and quality. Responsibilities include: contribute to CRF and SDTM standard development , support develop, implement, and maintain Analysis Data Model (ADaM) dataset… more
- Tris Pharma (Monmouth Junction, NJ)
- …privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We ... for an experienced MD to serve as Senior Director or Director, Clinical Development . Title and salary commensurate with experience. The position is a core member… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the ... data, information, and formats required for inclusion in these applications Manages simple development projects or portions of projects May act as FDA liaison for… more
- Tris Pharma (Monmouth Junction, NJ)
- …opening in our Monmouth Junction, NJ facility for a Senior Manager, Business Development .The primary role of the Senior Manager, Business Development is to ... with a range of internal functions to support business development and other strategic initiatives. This includes, but is...Pharma, Inc. offers a highly competitive compensation and benefits package . To build and enhance our diverse workforce, we… more
- Tris Pharma (Monmouth Junction, NJ)
- …privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet patient needs. ... specificationsProvides Engineering support and collaborates cross functionally with Operations, Packaging and Manufacturing departments on appropriate qualification, programming and… more
- Tris Pharma (Monmouth Junction, NJ)
- …privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet patient needs. ... a cGMP regulated environment in a pharmaceutical or biotechnology Facilities, Packaging and/or Manufacturing department(s). Special knowledge or skills needed and/or… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewTheDirector, Clinical Development will play an important role in working with the team to ... execute the global clinical development plans of brensocatib for the HSindication. Tasks include...and in the future. We offer a competitive total-rewards package to all employees around the world, including:Flexible approach… more
- Tris Pharma (Monmouth Junction, NJ)
- …privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We ... Director provides leadership, direction and medical expertise for company’s clinical development programs specifically focused on the treatment of Pain. The… more
- Insmed Incorporated (Bridgewater, NJ)
- …analytical activities performed at CROs/CDMOs associated with method development , qualification/validation, transfer and characterization for drug substance, drug ... standards. The Manager must possess a good understanding of pharmaceutical development processes from pre-clinical development through life-cycle management.… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces for Millennials™ lists.OverviewThe Associate Director, Commercial Learning & Development , will be a key member of the Commercial Effectiveness ... organization, primarily responsible for the successful development , delivery and management of comprehensive training (ie: product, skills, and market access… more
- Catalent (Philadelphia, PA)
- …company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, ... is Catalent's global Center of Excellence for Clinical Supply Packaging . Catalent offers GMP secondary packaging and...opportunities to further your career! Join the global drug development and delivery leader and help us bring over… more
- Merck & Co. (North Wales, PA)
- …Asset team. Our Company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of ... clinical development , including: study design, placement, monitoring, analysis, regulatory reporting,...open positions.If you have been offered a separation benefits package , but have not yet reached your separation date… more
- Tris Pharma (Monmouth Junction, NJ)
- …privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet patient needs. ... patient-friendly products that leverage our strengths in product selection, product development , commercial launch, and securing market share. Driven by innovation,… more
