- Genmab (NJ)
- …quality, and scientific integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our ... science through compelling clinical and regulatory documents. You'll be at the heart of a...experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates should also have knowledge of Health… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... (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)
- 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
- Genmab (NJ)
- …the above by developing and writing corresponding SAS or other programs. The Senior Programming Manager may also serve as a compound lead.Responsibilities/tasks ... for Programming Manager , at least 6-8 years of experience for Senior Programming ManagerHas experience working in a global contextProficient in both written and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Eisai, Inc (NJ)
- …using MS OfficeEisai Salary Transparency Language:The base salary range for the Senior Manager , eTMF System is from :114,600-150,500Under current guidelines, ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT...and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …engagements with customers. Relationships This position reports into a Director or Senior Director within the National Account Market Access Teams. Internally, this ... implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Collaborate With Downstream Account… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Manager of HCP Marketing will be a pivotal driver in shaping an insights-driven HCP ... market access and public affairs (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… more
- Daiichi Sankyo, Inc. (Bernards, 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 (Seattle, WA)
- …Business HoursHybrid: (50%&plus days onsite required, days of week are flexible)Job ID: 62721Per manager , the Top 3 - 5 Must Have's a candidate should have are:Top ... large data sets in support of batch history sections for regulatory submissions.Proficiency in data management/statistical analysis software, including Excel, JMP,… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... (written and verbal).-Ability to effectively influence key stakeholder groups (including senior and executive levels of an organization).-- Integrity - Stewardship… more
- Invenergy (Denver, CO)
- …be before or after the 3-day posting window. Job Description Position Overview The Manager / Senior Manager , Regulatory Affairs will represent Invenergy ... Regulatory Affairs: 125,000.00 - 150,000.00 USD Annual Bonus: 25% - 40% Senior Manager , Regulatory Affairs: 145,000.00 - 165,000.00 USD Annual Bonus: 25%… more
- Amazon (Phoenix, AZ)
- …you will manage several Pharmacists in Charge within a geographic region. The Senior Manager Regulatory Ops is responsible for maintaining adherence ... Description Amazon Pharmacy is seeking a Senior Manager , Regulatory Operations who is dedicated to patient safety to ensure compliance with regulatory … more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Clinical Regulatory will report to the Director, Clinical… more
- Liberty Utilities (Merrick, NY)
- Senior Manager , Rates and Regulatory Affairs Merrick, NY, US, 11566 **Our purpose is sustaining energy and water for life, and it is demonstrated in ... rewarding both the goal outcome and how we achieve it.** **Purpose** The Senior Manager Rates and Regulatory Affairs is responsible for all regulatory… more
- Scotiabank (New York, NY)
- Senior Manager , Regulatory Relations Group **Requisition ID:** 222217 **Salary Range:** 117,400.00 - 224,700.00 _Please note that the Salary Range shown is a ... continuous regulatory monitoring interactions, assisting with oversight of regulatory remediation and reporting to internal Bank senior management… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …other competencies necessary to ensure engaged and productive work environments. _The Senior Manager , International Regulatory Intelligence has the following ... reasonable accommodation to individuals with disabilities. **Brief Job Overview** The Senior International Regulatory Intelligence Manager will lead… more
- Stryker (Weston, FL)
- We are currently seeking a ** Senior Manager , Regulatory Affairs** to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). ... hybrid in Mahwah, NJ or Weston, FL with some workplace flexibility. As the ** Senior Manager , Regulatory Affairs** , you will lead and coordinate global … more
- AbbVie (San Francisco, CA)
- …Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager , RA Global Regulatory Strategy, US & ... driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development… more
