- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key... will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products...NNI, a self-starter who is self-led and keeps their manager up to date on progress and ensures no… more
- Merck & Co. (North Wales, PA)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Capstan (Santa Cruz, CA)
- …to join a well-funded, early-stage start-up positioned to revolutionize structural heart care. The Manager of Regulatory Affairs will help build and execute ... Reports to: Head of Regulatory Affairs (SVP, RA) Workplace type:...regulatory strategy in partnership with leadership, product, and clinical teams. Prepare, review, and submit high-quality and accurate… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …requirements and internal policies for medical affairs activities. Support regulatory submissions, including safety reporting, clinical trial data analysis, ... Kite, a Gilead company is hiring a Senior Medical Manager to support US Medical Affairs . As...development of scientific content for promotional and educational materials, clinical trial protocols, and regulatory submissions. Establish… more
- Medtronic (Irvine, CA)
- …innovation in a more connected, compassionate world. A Day in the Life The Sr Regulatory Affairs Specialist will play a key role in sustaining the current ... with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining … more
- IntePros (Audubon, PA)
- IntePros is currently looking for a Regulatory Affairs Associate to join one of our growing Medical Device clients in Audubon, PA. The Regulatory Affairs ... Experience should demonstrate dependability, flexibility and attention to detail. Regulatory Affairs Associate Job Requirements: Under supervision of… more
- Planet Pharma (Princeton, NJ)
- …Range: 37-47/hr *Depending on experience Job Category: Clinical Operations Job Title: Regulatory Publishing Manager I Duties The Manager /Sr. Manager , ... by advising on use of Veeva Vault RIM. *For clinical study reports, deliver Regulatory Operations kickoff...and change control processes. *Ability to work collaboratively with Regulatory Affairs , Medical Writing, and other functions… more
- Abbott (Santa Clara, CA)
- …other cross-functional deliverables. Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product ... as well as study sites as directed by your manager . What You'll Work On Writes clinical ... regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts… more
- Syneos Health Careers (Morrisville, NC)
- Description Clinical Project Manager II - post-trial access / EAP / rollover studies Syneos Health(R) is a leading fully integrated biopharmaceutical solutions ... organization built to accelerate customer success. We translate unique clinical , medical affairs and commercial insights into outcomes to address modern market… more
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. Working knowledge of GCP, Clinical and Regulatory Affairs . Proficient with Microsoft Suite. Travel ... data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed* Participate in cross-functional clinical … more
- Veterans Health Administration (Pittsburgh, PA)
- Summary The Community Living Center Nurse Manager functions as a clinical expert responsible and accountable for all elements of the nursing process when ... and equitable patient care. Ensures compliance with accreditation and regulatory standards. Aligns nursing/ clinical objectives with organizational strategic… more
- Globus Medical (Audubon, PA)
- …to FDA Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA ... can resume their lives as quickly as possible. Position Summary : The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for… more
- Kodiak Sciences Inc (Palo Alto, CA)
- …assist in audit and inspection readiness. Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs , and IT to ... headquarters in Palo Alto, CA. We are seeking a dedicated and detail-oriented Manager , Data Management to support data management activities for clinical trials.… more
- Veterans Health Administration (Chesapeake, VA)
- …owe allegiance to the US Videos Duties The Registered Nurse Inpatient Nurse Manager (NM) is the designated first-line supervisory authority and is responsible and ... provides coverage for other NMs as needed. Ensures compliance with accreditation and regulatory standards. Duties listed below but not limited to: Traveling 25% is… more
- Veterans Health Administration (Salisbury, NC)
- …of comprehensive medical services within the Sleep Program. The Sleep Medicine Program Manager will be accountable for maintaining high standards of patient care and ... OF ASSIGNED DUTIES: In addition to compliance with national and local regulatory , policy, and accreditation requirements governing this health care system, this… more
- Veterans Health Administration (Cape Coral, FL)
- …orientation, training, and competency assessment of staff to meet regulatory requirements. Implements and monitors quality management activities. Provides corrective ... laboratory's contingency plan and the need to inform the manager or designee of any issues. Submit work orders...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Basic Requirements United… more
- Veterans Health Administration (Albany, NY)
- …writing, with a wide variety of individuals, including technical and professional clinical staff, to communicate technical information. Serves as a project ... manager /construction manager responsible for the overall management,...the program. Negotiates and integrates all station functions (ie, clinical , administrative, safety, planning, construction, contracting, etc.), customer needs,… more
