- Insmed Incorporated (San Diego, CA)
- …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... lead the central messaging, preparation, and submission of high quality , regulatory complaint regulatory dossiersDirect...communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …toward building a quality mindset with Medical Affairs .Support the Sr. Director 's Medical Affairs Quality strategy by partnering with members and ... the Quality organization at senior levels. The Director plays a pivotal role in regulatory ...Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews of… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our ... regulatory submissions, maintaining licences and liaising with government authorities.The Regulatory Affairs Manager plays a critical part in ensuring… more
- Merck & Co. (Rahway, NJ)
- …we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality ... projects as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays...are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence,… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Merck & Co. (Millsboro, DE)
- …Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... leaders and frontline teams, and who works effectively across functional partners. Quality - and compliance-focused with practical experience supporting regulatory … more
- Insmed Incorporated (San Diego, CA)
- …with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.ResponsibilitiesEDC System Design & ... solutions comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance:Ensure EDC systems comply with regulatory requirements (eg, FDA,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based ... research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …or fellowship in a related field.Proven leadership abilities, strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management ... target product profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design… more
- buyer (New York, NY)
- … Officer.Minimum Qualifications* Bachelor's degree required; and* 5+ years of Regulatory Affairs work experience; or* A satisfactory equivalent combination ... any changes or updates to regulations. The position is accountable for supporting the Director of State Regulatory Guidance and will provide, as well as oversee,… more
- Massachusetts Psychological Association (Wellesley, MA)
- Description The Massachusetts Psychological Association (MPA) is seeking a Director of Professional Affairs . The purpose of the Massachusetts Psychological ... In accordance with the MPA Constitution and Bylaws, the Director of Professional Affairs (DPA) is responsible...monthly, as appropriate, updates on matters related to legislative affairs , regulatory issues, and health plan meetings… more
- Inside Higher Ed (Boston, MA)
- …approach to curriculum design.Lead data-informed program assessment and continuous quality improvement efforts.Student Affairs and SuccessWork collaboratively ... means to be part of Mass General Brigham. Job SummaryThe Associate Dean of Academic Affairs in the School of Nursing (SON) holds a ranked faculty position at the MGH… more
- City of Canby, OR (Canby, OR)
- …Position Overview The City of Canby is recruiting to fill the role of Finance Director . The ideal candidate will bring a positive energy to the City while providing ... goal setting for the City's Finance Department to ensure delivery of quality municipal services. Responsible for financial and strategic planning for all financial… more
- Programmable Medicine Operatin (Redwood City, CA)
- …team meetings and sub-team meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug ... our external contract manufacturing network while ensuring compliance with cGMP, regulatory requirements. This is an individual contributor, hands-on position. As… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …in internal and external audits. Cross-Functional Collaboration Collaborate closely with Sales, Regulatory Affairs , Logistics, Finance, and Supply Chain to align ... Description Job Title : Manager, Customer Service Supervisor/Manager Title: Senior Director of Global Commercial Operations and Strategy Job Description Summary: The… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Senior Associate, Clinical Research Supervisor/Manager Title: Senior Manager, Clinical Affairs Job Description Summary: The Senior Clinical Research Associate will ... report to the Associate Director , Clinical Programs, and will play a key role...of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate will have a thorough… more
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of ... throughout the organization. The Senior Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading, and… more
- Kelly Services (Anaheim, CA)
- ** Director of Quality and Regulatory Affairs ** Kelly(R) Science & Clinical is seeking a ** Director of Quality and Regulatory Affairs ** ... In this role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development,… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality ! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA) teams by proactively identifying and managing regulatory / quality risks and… more
