- Merck & Co. (Upper Gwynedd, PA)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5… more
- Merck & Co. (North Wales, PA)
- …to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance . - Work closely with the Corporate Business Development, ... Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory … more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...the regional regulatory strategy, objectives, policies, and programs pertaining to developing… more
- Merck & Co. (Boston, MA)
- …monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical… more
- CHRISTUS Health (Alexandria, LA)
- …programs as needed to comply with diverse healthcare laws or regulations Monitors regulatory compliance of all healthcare practices to ensure no violations ... Clinical Policies and Standards Monitors different types of clinical practice to ensure compliance with standards...different types of clinical practice to ensure compliance with standards Evaluates existing and evolving standards and… more
- Merck & Co. (Rahway, NJ)
- …effective, innovative medicine.Summary, Focus and Purpose:The Cardiovascular and Respiratory Clinical Research Director -has primary responsibility for planning ... cardiovascular and respiratory medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… more
- Insmed Incorporated (NJ)
- … regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with ... meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities ... and execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop… more
- Eisai, Inc (Baltimore, MD)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs),… more
- Eisai, Inc (Nutley, NJ)
- …15 or more years significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in ... and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products… more
- GRAIL (Menlo Park, CA)
- …partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director , Clinical Compliance will play a key leadership ... + years relevant experience in clinical quality assurance, diagnostics, and/or regulatory compliance within the diagnostics, or medical device field. +… more
- InterDent (Portland, OR)
- …oral and systemic health outcomes. Position Overview We are seeking a dynamic Regional Clinical Director (RCD) to provide clinical leadership and operational ... Dental Care's dental programs, ensuring alignment with evidence-based practices and regulatory compliance across Medicaid, Medicare, and PACE. Develop,… more
- HealthCare Support (Bronx, NY)
- …Leads interdisciplinary teams in delivering coordinated participant care and maintaining regulatory compliance Facilitates care planning meetings to ensure ... Assistant Clinical Service Director - Registered Nurse HealthCare Support is seeking a Registered Nurse to fill an opening as an Assistant Clinical Service … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Medalogix (Nashville, TN)
- …and external information and guidance in clinical , operational, and regulatory matters to ensure compliance with applicable standards and regulations. ... more about the merging of Forcura and Medalogix. Position Summary The Director , Clinical Operations leverages his/her extensive knowledge managing multiple… more
- Highland Hospital (Rochester, NY)
- **17220BR** **Title:** Director of Pharmacy, Clinical Services **Department/Cost Center:** 751 - Pharmacy **Job Description:** *Highland Hospital is seeking a ... Director of Pharmacy for Clinical Services! This...will: maintain standards set by the department, institution, and regulatory agencies in the establishment and leadership of high… more
- DERMCARE MANAGEMENT LLC (Hollywood, FL)
- …opportunities. Ensure team members maintain required certifications and training for regulatory compliance . Organize regular project reviews and meetings to ... Not Specified Travel Percentage Road Warrior Job Category Research Description The Regional Director of Clinical Operations plays a key leadership role in… more
- Stony Brook University (Stony Brook, NY)
- …Stony Brook Medicine's Healthcare Epidemiology Department. The Director of the Clinical Microbiology laboratory ensures regulatory compliance with New ... Associate, or Full Professor level (Clinician Educator track) to provide laboratory director oversight for the clinical microbiology laboratory section of the… more
- Organon & Co. (Plymouth Meeting, PA)
- …is expected to participate in cross-functional development programs with early clinical development, late- clinical development, regulatory affairs, safety ... position will also be responsible for reviewing and authoring non- clinical and clinical modules for regulatory...documents of assets in Organon portfolio. + Ensure that non- clinical studies are conducted in compliance with… more
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