- Olema Oncology (San Francisco, CA)
- …As the Director , Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of labeling ... end-to-end label implementation. This role will work closely internally with Regulatory Affairs , Clinical Development, Clinical Supply (CS), Quality Assurance… more
- Supernus Pharmaceuticals, Inc. (Rockville, MD)
- …Supernus products. Essential Duties & Responsibilities: Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this ... and promotional materials for assigned products, submission of materials, and representing Regulatory Affairs on promotional review committee. Acts as primary… more
- Duke University (Durham, NC)
- …discover how we can advance health together. Position Summary The Assistant Director , Accreditation and Regulatory is responsible for leading system ... adoption of the system's governance and committee review framework. The Assistant Director also brings expertise in regulatory standards and improvement… more
- Mattel (El Segundo, CA)
- …all our brands, partners, and suppliers. The Team: The Global Quality, Safety , Regulatory Compliance, Governance & Risk, Consumer Services, and Sustainability ... those changes into the future environment, in partnership with government affairs , legal, finance, and regulatory compliance colleagues. Resource Allocation:… more
- Genmab (NJ)
- …various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , ... like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for… more
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance, and supporting audits are also part of the… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle ... digital experience across HCPs, Consumers, and SOC to drive adherence and safety as patients start therapy. Partner with Market Access, Eisai Patient Support,… more
- Invivyd (New Haven, CT)
- …and Safety Data Exchange Agreements. Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge ... difference. Be part of Invivyd. Job Title: Senior Manager/Associate Director , Drug Safety and Pharmacovigilance Operations Position...of regulatory safety reporting guidelines and implementing relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … collaborations within and across line functions, eg Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Operations. Formulates strategic ... interfaces with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge. This position… more
- Lifelancer (London, KY)
- … interactions. Cross-Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs , Program Management, CMC, and external CROs ... About the job Sr Medical Director Job Title: Sr Medical Director ...of key clinical documents, including protocols, IBs, CSRs, and regulatory submissions. Regulatory & Safety … more
- Deciphera Pharmaceuticals (Waltham, MA)
- …support key decision-making, drive conclusions and develop next steps Work closely with Regulatory Affairs , and other cross functional team members to ensure ... Company Description Job Description We are seeking a Medical Director . This position will report to the Senior Medical Director of Pharmacovigilance and will be… more
- LanceSoft (Cambridge, MA)
- …functionally and leading the development of required processes (eg, with Global Regulatory Affairs , Data Sciences). Ensures that Client Signal Management ... Job Title: Director , Signal Management Location: Cambridge, MA 02139 -...visualizations in the form of graphics and tables for regulatory reporting, internal safety updates, signal evaluations… more
- Stanford University (Stanford, CA)
- …, student affairs , external relations, and human resources. Additionally, the Director of Finance and Administration works with the Chair and other faculty and ... hospitals to achieve organizational goals and results. Reporting Relationships The Director of Finance and Administration (DFA) has a primary reporting relationship… more
- Barrington James (Madison, OH)
- … regulatory filings. Cross-Functional Collaboration Work closely with Clinical Operations, Regulatory Affairs , Safety , Program Management, and external ... Medical Director , Clinical Development (Oncology) Location: US Remote A...and external stakeholders, including during site selection and initiation. Regulatory & Safety Responsibilities Support the preparation… more
- Urban Resource Institute (New York, NY)
- …communities of color and other disenfranchised populations, to increase their safety and resiliency. Today, URI is maximizing the impact of organizational ... in the sector across the US and beyond. POSITION OVERVIEW The Clinical Director provides strategic leadership to Urban Resource Institute's clinical staff and across… more
- MannKind Corporation (Bedford, MA)
- …compliance and best practices. Partner with cross-functional teams, including clinical development, medical affairs , regulatory affairs , safety to ensure ... including but not limited to study protocols, CSRs, DSURS, IB, safety narratives, publications and submission documents. This role involves providing medical… more
- Piney Technical Services (Kansas City, MO)
- …Description The Regulatory Specialist, located in Kansas City, MO reporting to Director Regulatory Affairs , is responsible for preparing, amending, and ... Canada requirements. Evaluate label changes and marketing materials for regulatory compliance. Review and communicate any health, safety...and Manufacturing. Work with other members of the Global Regulatory Affairs team to help solve global… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …processes and training and ensure alignment with global processes and regulatory requirements and expectations. Drive the implementation and change management of ... Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. Provide expert advice and support to the… more
- Merck & Co. (Rahway, NJ)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
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