PSG Global Solutions Careers
Associate Manager of Training and Development
PSG Global Solutions Careers, Irvine, California, United States, 92713
Apply now and our proprietary system will quickly have you in front of a live recruiter.The OpportunityDescriptionWe're looking for an
Associate Manager of Training and Development , working in
Pharmaceuticals and Medical Products
industry in
2525 Dupont Drive, Irvine, California, 92612, United States .
Job description:Collaborating globally with functional process owners within R&D to drive the development, revision, implementation and retirement of R&D processes.Driving the review and approval workflow and function as an administrator within the document development and management systems.Ensuring alignment with regulations and company policies and consistency across processes.Identifying process-related issues and support process improvements.Supporting the preparation and conduct of audits and health authority inspections.Regularly update industry and company specific knowledge and continuously improve skills related to the development, documentation and management of processes.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Requirements:
BA/BS with 6 years of experience in research and development (MS/MA in related field may substitute for 1 year of experience)At least 2 years at advanced management and operations levelsAt least 3 years directly related to management of systems and processes in a regulated environmentKnowledge:
Excellent knowledge of GxP, ICH guidelines, PhRMA code, FDA CFR, ISO clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulationsProficient with electronic document management systems (EDMS) and business process mapping systems (e.g. Nimbus, TaskMap)Proficient with processes required for the creation of robust processes and proceduresKnowledge of clinical study operations and the drug development processKnowledge of concepts of clinical research and drug developmentProficient with electronic systems including, Visio, MicroSoft Office Suite, SharePoint, WebExCompetencies:
Ability to handle and prioritize multiple prioritiesSelf-starter with ability to work independently at the regional or global level with remote or minimal supervisionAbility to work effectively in a team/matrix environmentAbility to influence others without direct reporting relationshipsAbility to understand technical, scientific and medical informationDemonstrated strengths in customer service, planning, organizational, project management and analytical skills, oral and written communication, time management, negotiation, conflict management and resolution, attention to detail, interpersonal and networking skills, relationship building, cross-cultural sensitivity
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
Associate Manager of Training and Development , working in
Pharmaceuticals and Medical Products
industry in
2525 Dupont Drive, Irvine, California, 92612, United States .
Job description:Collaborating globally with functional process owners within R&D to drive the development, revision, implementation and retirement of R&D processes.Driving the review and approval workflow and function as an administrator within the document development and management systems.Ensuring alignment with regulations and company policies and consistency across processes.Identifying process-related issues and support process improvements.Supporting the preparation and conduct of audits and health authority inspections.Regularly update industry and company specific knowledge and continuously improve skills related to the development, documentation and management of processes.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Requirements:
BA/BS with 6 years of experience in research and development (MS/MA in related field may substitute for 1 year of experience)At least 2 years at advanced management and operations levelsAt least 3 years directly related to management of systems and processes in a regulated environmentKnowledge:
Excellent knowledge of GxP, ICH guidelines, PhRMA code, FDA CFR, ISO clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulationsProficient with electronic document management systems (EDMS) and business process mapping systems (e.g. Nimbus, TaskMap)Proficient with processes required for the creation of robust processes and proceduresKnowledge of clinical study operations and the drug development processKnowledge of concepts of clinical research and drug developmentProficient with electronic systems including, Visio, MicroSoft Office Suite, SharePoint, WebExCompetencies:
Ability to handle and prioritize multiple prioritiesSelf-starter with ability to work independently at the regional or global level with remote or minimal supervisionAbility to work effectively in a team/matrix environmentAbility to influence others without direct reporting relationshipsAbility to understand technical, scientific and medical informationDemonstrated strengths in customer service, planning, organizational, project management and analytical skills, oral and written communication, time management, negotiation, conflict management and resolution, attention to detail, interpersonal and networking skills, relationship building, cross-cultural sensitivity
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?