- Merck & Co. (North Wales, PA)
- … Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage CMC programs, due diligence and business ... more junior staff in the nuances of managing a CMC project : management of team dynamics, understanding...Budgeting, Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Senior Manager , Global Regulatory Affairs, CMC Small Molecules where you will ... oversee the development and execution of regulatory CMC development and registration strategies. You...You will be RA CMC member on Regulatory , Pharmaceutical Development, and Production project teams… more
- BeOne Medicines (San Mateo, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Merck (North Wales, PA)
- … Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage CMC programs, due diligence and business ... more junior staff in the nuances of managing a CMC project : management of team dynamics, understanding...Budgeting, Project Management, Project Planning, Project Scheduling, Project Strategy, Regulatory … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- AbbVie (North Chicago, IL)
- …finished product. As a team member in interdisciplinary product development teams (eg, CMC teams), the Senior Manager is responsible for early identification and ... AbbVie R&D functions and external partners. Responsibilities: + QA representative for CMC product development teams to facilitate the approval of drug to clinical… more
- Adecco US, Inc. (Cambridge, MA)
- …of small-molecule oral dosage forms. + Proven track record as a ** project manager of technical projects** with multi-disciplinary, cross-functional teams. + ... submissions, and product control. + Support MSAT Program Directors and CMC Leaders by planning, coordinating, and tracking project activities, including:… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC .** **As assigned, supports development of CSL policy positions ... meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Hematology ? The...**e.g.** **GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead? The job is in our King of Prussia,… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Bristol Myers Squibb (Summit, NJ)
- …(CAR) T-cell Therapies. The role will report to the Sr. Manager of CAR T Project management. The project manager will develop project plans and ... with our Cell Therapy team. This position will support the Sr. Manager in managing multiple large-scale projects needed for multi-product manufacturing, including… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... as regulatory decision maker/approver for GRAST / GRA related project deliverables as needed. Within GRAST, effectively foster two-communication between GRAST… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- AbbVie (North Chicago, IL)
- …Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Manager a small team (3 ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
- Cambrex High Point (Longmont, CO)
- …Overview Cambrex is seeking to hire a growth-related Research Investigator & Manager position with a highly motivated individual for the Process Chemistry ... substance manufacturing requirements, and substantial experience with GMP practices, CMC principals and ICH guidelines for pharmaceutical development. Deep knowledge… more
- Takeda Pharmaceuticals (Lexington, MA)
- …progress; manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + ... in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical… more
- ERP International (Cherry Point, NC)
- …Case Manager (RN-NCM) o National Academy of Certified Care Managers: Care Manager Certified ( CMC **)** Experience:** One year of experience in nursing as ... ERP International is seeking full-time **Registered Nurse (RN) Case Manager ** in support of theNaval Health Clinic Cherry Point,...in Montgomery, AL and San Antonio, TX - plus project locations nationwide. ERP is an Equal Opportunity Employer… more
- Houston Methodist (The Woodlands, TX)
- At Houston Methodist, the Case Manager (CM) Certified position is a registered nurse (RN) responsible for comprehensively planning for case management of a targeted ... initiates discussion with attending physicians, coordinates with the external case manager to facilitate discharge planning, seeks assistance from the physician… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Case Manager (CM) Advanced position is a registered nurse (RN) responsible for promoting the achievement of optimal clinical and resource ... level at all the objectives delineated in the Case Manager and Case Manager Certified job roles...families and works with the leadership team for special project activities related but not limited to, throughput, readmissions,… more
- ERP International (Yuma, AZ)
- **Overview** ERP International, LLC is seeking a **Registered Nurse - Case Manager ** for a full-time position at the Camp Pendleton **Branch Health Clinic** in ... in Montgomery, AL and San Antonio, TX - plus project locations nationwide. ERP is an Equal Opportunity Employer...+ Maintain adherence to JCAHO, URAC, CMSA and other regulatory requirements. Apply medical care criteria (eg, InterQual). +… more
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