- Tris Pharma (Monmouth Junction, NJ)
- …to hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior ... materials, activities and related communications and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internally and with external parties. Ensure that all employees are in compliance with all contract requirementsSupport the Associate Director Global Strategy ... Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In… more
- Eisai, Inc (San Diego, CA)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines.Strong knowledge of key laws and regulations ... is your profile, we want to hear from you. Job Summary The Sr . Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology… more
- Eisai, Inc (Louisville, KY)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines.Strong knowledge of key laws and regulations ... is your profile, we want to hear from you. Job Summary The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a hybrid ... Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Windstream (Columbus, OH)
- …Material Coordinators to maintain a clean and organized facility. Work closely with Sr Director Logistics and other related departments to provide solutions to ... Windstream inventory assets. This position reports directly to the Sr . Director of Logistics and works closely...required to notify and to obtain approval from federal regulatory agencies prior to granting certain system/network access to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus even under adversity Operational mindset and continuous improvement: Considers compliance , regulatory , quality assurance and other requirements when ... Category Leaders and Managers Scopes out high-profile supplier engagements for senior level executives, develops and negotiates agreements and manages suppliers to… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… 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, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , US Market Access Contracting sits within the National Contract Operations and Supply Chain Team (NCOSC), which delivers best-in-class, ... and Infusion companies for our Company's commercial and government business.-The Director , US Market Access Contracting reports to the Executive Director… more
- Merck & Co. (Rahway, NJ)
- …of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document ... disclosure, and data sharing with external researchers. The Executive Director in Medical Writing will be responsible for overseeing clinical trial data… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology approvals in the Design Authority.- They will ensure the smooth… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team based ... Represent MSAT at joint quality and CMC committeesPartner closely with senior Janssen leadership to achieve global alignment on all validation Carvykti… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand marketing, market access, commercial effectiveness, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... teams, Brand Marketing, Training, Commercial Insights and Analytics, Managed Markets, Legal, Compliance , and Finance. The position has high exposure to senior … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in sales, sales training, and marketing ... etc )Responsibilities Interaction & Collaboration level: Requires interaction with key senior stakeholders at director level and above cross functionally… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of… more