- Novo Nordisk Inc. (Plainsboro, NJ)
- …agencies. Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/ Sr . Manager Regulatory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D… more
- Aequor (Thousand Oaks, CA)
- Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead ... responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses… more
- Aequor (Newbury Park, CA)
- …affairs processes and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission ... zone based on business needs in the evenings. Ideal Candidate: Previous Regulatory Experience professionally is highly preferred. Knowledge of FDA. Degree in life… more
- Aequor (Thousand Oaks, CA)
- Remote role - need to work Pacific zone hours Manager would prefer candidates who are local to sit to support site operations once a week to once a month depending ... Serve as the primary interface with Clinical Development, Quality, Biostatistics, Regulatory Affairs, Corporate Planning, and Operations to ensure coordination of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Aequor (Thousand Oaks, CA)
- …remote schedule and be available at the committed times. Qualities/characteristics the hiring manager is looking for in candidates to work best with their team: ... Proactive, go-getter, detailed oriented, customer service oriented Things the hiring manager is looking for when reviewing resumes that stand out among the right… more
- Tris Pharma (Monmouth Junction, NJ)
- …globally. We have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ... due diligence process, and succinctly present findings and recommendations to senior management Lead critical aspects of the technology partnership process: identify… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Data Science and Evidence (CDSE) Real World Evidence (RWE) team. Relationships The Senior Manager reports directly to a Senior Director within the ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... publicationsUnderstand, coordinate, and document adherence to internal, external, and regulatory compliance requirementsCollaborate extensively and troubleshoot issues by providing… more
- Aequor (Thousand Oaks, CA)
- …group. Ability to evaluate documentation/ operations according to company and regulatory guidelines Ability to interact with regulatory agencies. Demonstrate ... SAP Projects Must have Looking for candidates with 10&plus years of experience. Travel required about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility… more
- Merck & Co. (Rahway, NJ)
- …preferred.Required experience and skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH).Ability to manage multiple competing ... priorities with good planning, time management and prioritization skills.Solid understanding of the principles of project planning & project management.Good analytical skills to drive operational milestones.Influence opinions and decisions of internal and… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately ... system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the Senior Manager , Medical Writing is from :126,300-165,800Under current… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with ... project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise and input… more
- Novo Nordisk Inc. (Boulder, CO)
- …we are driving change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a ... and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at...raw materials, during the execution of his/her duties, the Manager / Senior Manager should seek to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reach the people who need them most. The Position As an Adobe Experience Manager (AEM) UX Architect, your primary responsibility will be to design and deliver ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… more
- Lundbeck (Chicago, IL)
- …journey of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for ... sales management training needs by observing individual Biopharmaceutical Account Manager performance/behaviors and collaborating with the appropriate functional areas… more
- Novo Nordisk Inc. (Durham, NC)
- …the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive & coach teams ... others credit for their contributions & successes Effectively uses rewards & recognition to help individuals & team achieve desired results is required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... statistical methodologies.- Some understanding of current drug development trends and regulatory environments.- Sufficient programming skills in SAS and/or R and… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the...may oversee a staff from five to ten including Sr QA Technical Reviewers and QA Product Managers. Responsible… more
