- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities ... responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses… 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
- 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
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical ... compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing… more
- Aequor (Thousand Oaks, CA)
- …around technology development. Enterprise level engagement. Job Title: Senior Project Manager - End to End Regulatory Content Automation Initiative, Global ... of 5-8 YOE in project management within R&D and regulatory affairs, within pharmaceutical. Not a tech expert but...Strategy, Position Summary: We are seeking a seasoned Project Manager with a proven track record in the pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Paid Media, Medical, Managed Markets, Corporate Communications and Public Affairs, Regulatory , Privacy, Sales, and Legal. Will also interact with NNA/S on ... content management functions for all NNI internet sites Manage PRB (medical, legal, regulatory ) review of NNI internet site and its waterfall of content Manage… more
- Merck & Co. (North Wales, PA)
- …in the Research & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug ... strategies and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive… 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the successful execution of brand-level marketing ... required Proven knowledge of the pharmaceutical industry, including medical, regulatory , clinical processes and market dynamics, especially within diabetes preferred… more
- Aequor (Thousand Oaks, CA)
- The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global Distribution ... Facing SKU Change Records (CFSCR) Provide timely updates to stakeholders, eg, Regulatory , Supply Chain, Manufacturing, Quality on status of GDCR and/or CFSCR… more
- Novo Nordisk Inc. (Boulder, CO)
- …GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… 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
- Tris Pharma (Monmouth Junction, NJ)
- …an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior Director, Clinical Operations provides expert ... escalation of issues for trial or program level deliverables to senior management, etc.); Develops, implements, and/or manages adequate systems and procedures… 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)
- …overall operation. Relationships The Technical Team Lead, API Manufacturing reports to the Senior Manager , API Manufacturing. The Technical Team Lead works with ... The Technical Team Lead, API Manufacturing acts as a delegate for the Senior Manager API Manufacturing. Essential Functions Responsible for the manufacture of… more
