Job Description General Summary: The Director GMP Quality Operations is responsible for the quality oversight... of operations of the manufacturing site for the manufacture of Cell Product, including management of direct reports and defining...
partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies... documents and sections of regulatory submissions to support all phases of clinical drug development. This role may represent...
to inform program strategy. Monitor the development of new requirements, guidelines and trends through information gathering... organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling...
, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.). Prepare...s Degree in a related field 7 years in pharmaceutical industry regulatory affairs Strong knowledge of US drug development...
strong leadership and a focus on continuous talent development to attract and retain top talent in a highly competitive environment... Mentors the development of others, motivates personnel, and resolves conflicts Ensures goal setting of team members...
analysis, visualization, and interpretation of large scale genomic data in a drug development context. Excellent scientific... team and broader site goals Provides strong leadership and a focus on continuous talent development to attract and retain...
, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic... partner functions (e.g., pharmacometrics, statistics, and DMPK). Enables impactful Model-Informed Drug Development (MIDD...
and areas for improvement in the claim management process Insurance Program Management Lead insurance renewal strategy... etc. to enhance program Utilize Insurance Broker resources to provide 3rd party audits with development of action plans...
and compliance Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all project-related... analytical control topics, development requirements and program milestones including global reporting Oversee and manage core...
clinical drug development. Proven experience in design, conduct and data analysis of registration-track global clinical trials... treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS...
ore related field. Additional Qualifications and Skills Industry project management and/or drug discovery experience... as a key member of the Therapeutics Initiatives drug discovery program. As a member of the Therapeutics Initiatives project...
as requested by management staff. Administrative Responsibilities: * Assists the Director of Nutrition in the development... entrepreneurial proficiency in program patient volume and growth. Works with Director of Nutrition to establish and manage volume...
, accommodation, and logistics for director attendance at meetings. Manage the payment of directors’ fees and their expenses. Ensure... document management and workflow tools. Experience with board portal technology solutions such as BoardVantage or Diligent...
as requested by management staff. Administrative Responsibilities: * Assists the Director of Nutrition in the development... entrepreneurial proficiency in program patient volume and growth. Works with Director of Nutrition to establish and manage volume...
and daily management of school- and community-based training in iDECIDE, a drug education and diversion program. · Create... Research and Program Development for the Center for Addiction Medicine, focused on community-based approaches to address...
and daily management of school- and community-based training in iDECIDE, a drug education and diversion program. · Create... Research and Program Development for the Center for Addiction Medicine, focused on community-based approaches to address...
, PCS line functions and BR/Novartis Development project/program teams in managing the preparation and presentation... safety issue awareness of these modalities 3 plus years experience in a nonclinical drug development scientific discipline...
Form(s). Lead the development of contingency/risk management plans for projects and assist Director/Senior Director... activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge...
childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation... or established EHS program. Demonstrated relationship-building, problem-solving, and cross-functional collaboration skills...
program strategy, value, and impact is in the leadership and development HQ-based Case Management team and our field-based... manufacturer, our commitment extends beyond drug development ensuring that patients can access and afford our therapies. The...