- Novo Nordisk Inc. (Plainsboro, NJ)
- …Core Process Groups Physical Requirements Approximately 10% overnight domestic and/or international travel. Development Of People Supervisory. Ensure that ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...utilizing Standard Problem Solving (SPS) methods and strong CAPA development within the NN deviation IT platform Serve as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …meetings, as necessary Physical Requirements Approximately 10% overnight domestic and/or international travel. Development Of People Supervisory. Ensure that ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...management, and system management to influence process and system development in a manner consistent with global affiliate health… more
- Lundbeck (Bothell, WA)
- …Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC ... Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line ...electronic lab notebooks such as Benchling TRAVEL Domestic and international travel up to 10% may be required The… more
- Genmab (NJ)
- …us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and ... as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice ... with Medical Information Education (ME)- Support global medical communication plan development by collaborating with GMA team- Support other global data… more
- Merck & Co. (Millsboro, DE)
- …submissions and communications with the USDA, internal MAH departments or international permittees, where applicable.May serve as subject matter expert in regulatory ... where applicable. Additionally, may lead in creation of GRA standard international dossiers for US Biologicals.May review market advertising and promotions (A&P)… more
- Merck & Co. (Boston, MA)
- …the worldwide clinical and academic community to positively impact Research and Development (R&D) strategy for new medicines and to improve outcomes for patients. ... leads a large investigator-initiated studies program in partnership with late-stage development teams in Medical Affairs while also supporting early-stage … more
- Merck & Co. (Rahway, NJ)
- …Medicines. Our company's Neuroscience Medicines span all phases of clinical development (pre-clinical to post-licensure). With a focus on late-stage development ... the Senior Director will manage the entire cycle of clinical development , including study design, initiation, execution,- monitoring, analysis, regulatory reporting,… more
- Tris Pharma (Monmouth Junction, NJ)
- Analytical Research and Development Scientist II Monmouth Junction, NJDepartment: Analytical Research and Development and Characterization / Analytical ... a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders,… more
- Genmab (NJ)
- …and Intelligence Associate Director will primarily be responsible for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, ... for advising teams on global labeling strategies based on Genmab's development programs, target product profile, and competitive labeling precedent.Act as Global… more
- Insmed Incorporated (San Diego, CA)
- …related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by Clinical Operations ... all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role… more
- Genmab (NJ)
- …to support both Genmab approved products and those in various phases of development . MSLs provide medical information through scientific exchange in a fair and ... we thrive on connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients… more
- Genmab (NJ)
- …Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of concept, ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve… more
- Merck & Co. (Rahway, NJ)
- …and vaccine inventions. The position will support programs in all phases of development , from discovery through development and commercialization, and allows for ... and interaction with major areas of the business including discovery, development , manufacturing and supply, regulatory, business development , commercial groups,… more
- Tris Pharma (Monmouth Junction, NJ)
- …is a leading privately-owned biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, ... pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the US We also license… more
- Aequor (East Syracuse, NY)
- …assays) is preferred. Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and ... Travel This position may require up to 5% of domestic and/or international travel. Responsibilities Position Summary The Contractor Scientist within the Analytical… more
- Merck & Co. (Rahway, NJ)
- …and Scientific Affairs (GMSA) (referred to as EDMA) is accountable for the development and execution of scientific & medical affairs plans for their assigned Therapy ... scientific leaders and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders. They collaborate with V&I Outcomes… more
- Tris Pharma (Nashville, TN)
- …is a leading privately-owned US biopharmaceutical company focusing on development and commercialization of innovative medicines addressing unmet patient needs. ... We have over 150 US and International patents - including applications - and several marketed...We have licensed our products in the US and international markets and have a robust pipeline of innovative… 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 ... SMEs, process management, and system management to influence process and system development in a manner consistent with global affiliate health authority and/or… more
- Merck & Co. (Upper Gwynedd, PA)
- …Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development , Regulatory Affairs Compliance, Regulatory Affairs Management, ... the preparation and submission of CMC dossiers for all assigned development products. -Primary responsibilities include, but are not limited to:Regulatory… more
