- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assessment and recommends developmental options with supervision, and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) ... assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) ... and system development in a manner consistent with global affiliate health authority and/or stakeholder requirements Participates and or provides support to audits… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) ... deviations to ensure alignment with NN requirements and external health authority regulations Develops comprehensive, relevant resources (eg training program, FAQs)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit program and effective CAPA management resulting from audits, health authority inspections across the organization and affiliates as appropriate for the ... using a risk-based approach to ensure the Audit Plans are aligned with the company 's strategy and objectives and adjust the plan as needed to support business… more
- Genmab (NJ)
- …protocols, investigator's brochures, and clinical study reports.Contribute to Health Authority briefing documents and responses, and clinical modules of regulatory ... Senior level candidates should also have knowledge of Health Authority briefing packages, Health Authority responses, and...be innovativeYou have experience working in a fast-growing, dynamic company (or a strong desire to)You work hard and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to CDx for Health Authority interactions (for ... with the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation : Assist with preparation of pre-submission documents and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) ... and system development in a manner consistent with global affiliate health authority and/or stakeholder requirements Participates and or provides support to NAO… more
- Merck & Co. (North Wales, PA)
- …responsible and accountable for the end-to-end statistical support for a number our company 's late-stage products in Oncology. The AVP will work under the direction ... excellenceRepresents the statistics department at internal governance meetings, health authority meetings, advisory committee meetings, and statistical conferences, showcasing… more
- Formation Bio (New York, NY)
- About Formation BioFormation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ... concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia,… more
- Merck & Co. (Rahway, NJ)
- …Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company 's Device Development & Technology (DD&T) Team designs, develops, and ... manages the development of the device constituent of our company 's pipeline of combination products across a variety of...and a strategic thinker; able to influence without formal authority ; ability to influence and present ideas to senior… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company 's Device Product & Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, and ... and commercialization of the device constituent and combination product of our company 's pipeline of combination products across a variety of therapy areas and… more
- Merck & Co. (South San Francisco, CA)
- …other training, supervisory and management activities as required by the company .Education:PhD requiredMD or MD/PhD is a plusOther Qualifications:10+ years of ... to set and manage stakeholder expectations, ability to influence without authority .Ability to work effectively in a matrixed environment, ability to manage… more
- Merck & Co. (Upper Gwynedd, PA)
- …responsible for developing and implementing CMC regulatory strategies for our company 's pharmaceutical pipeline products in accordance with global regulations and ... original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.-Identify, communicate and… more
- Merck & Co. (Rahway, NJ)
- …Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company 's Research Laboratories (Research & Development) by:Developing an active engagement ... to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaboration skills with clear ability to impact and influence without authority Excellent at presenting complex technology concept to senior stakeholders Creative ... of factors. This position is also eligible for a company bonus based on individual and company ...a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management and Quantitative analysis skills Ability to lead and influence without authority and navigate within a matrix environment Strong Microsoft Excel and ... of factors. This position is also eligible for a company bonus based on individual and company ...a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and… more
- Tris Pharma (Nashville, TN)
- …Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focusing on development and commercialization of innovative medicines ... understand the criticality of operating a successful business and take pride in our company 's success. But of equal importance to each team member is how we interact… more
- Genmab (NJ)
- …Labeling Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States ... regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.Manage process for… more
- Eisai, Inc (Nutley, NJ)
- …caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... vendors, clinical documents, and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously… more
- Eisai, Inc (Nutley, NJ)
- …caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... meetings with other Health Authorities the CDE. Actively participates in Health Authority GCP inspections (eg, FDA, EMA, PMDA) including responding to observations… more
