- 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 (Newbury Park, CA)
- This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works regular hours (7a-4p or 8am-5p etc)/ with EST timezone ... Sigma method and project management experience. The type of qualities/characteristics the hiring manager is looking for in candidates that will work best with their… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director. Works with personnel ... to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to...on external regulatory initiatives Works with Group Manager to maintain surveillance of regulatory environment… 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
- 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
- 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
- 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)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with ... and performing data interpretation; and supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of… 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. (Durham, NC)
- …the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive & coach teams ... to ensure a high performing collaborative team environment, to include providing feedback, structure & accountability to continuously improve team engagement & performance Drive Mdev LCM and QA requirements at the site ensuring a high level of communication &… more
- Catalent (Harman, WV)
- …and eight additional suites coming online.Reporting to the Vice President and General Manager , the Senior Director Supply Chain directs all facets of supply ... Senior Director, Supply Chain Position Summary: The ...recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to procurement.Develop and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Boulder, CO)
- …solving skills, creativity, and initiative Please note we are open to hiring at senior Manager title commensurate with experience We commit to an inclusive ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… 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
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the implementation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and variances that occur during production or validationWork with Quality, Manufacturing, Regulatory , and subject matter experts to prepare for FDA and other agency ... across various product teams and global manufacturing sitesProvide updates to Senior Management on site validation status activitiesProvide validation training to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That strategy will… more
