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11 jobs found for training program coordinator

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    • san rafael, california
    • contract
    • $74.76 - $87.95 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: San Rafael, California job type: Contract salary: $74.76 - 87.95 per hour work hours: 8 to 4 education: Bachelors   responsibilities: Duties: Support the Global R&D and Regulatory Policy Team in the following policy activities: Monitor, review and inform stakeholders on recently published global regulatory policies and guidance documents impacting drug development - and of treatments for rare diseases and advanced therapies in particular.Provide project management support to the policy team in generation of comments on draft guidance's.Contributing as needed to all types of internal reporting (ad hoc memos, weekly summaries, highlights, digests etc.)If required, representing Company on trade association calls and meetings, and generate minutes for the benefit of the global head or regional leads.If required, attending external scientific and regulatory conferences, typically virtually, ensuring key intelligence and highlights are shared with the team and the rest of the organization.Supporting the preparation and follow-up of internal meetings with stakeholders and SMEs.Updating the team's trackers, engagement maps and SharePoint.Monitoring and documenting progression of the team objectives and key results (OKRs).Track Team memberships and involvement in policy trade associations and organizations.Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.Lead certain policy cross-functional meetings including minutes and action items.Provide strategic logistical support for managing policy calendars and deliverables.Develop and manage internal policy publications.Develop and manage dashboards for policy team initiatives.Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.Manage Trade Association List and Memberships including main contacts.Document project milestones/deliverables and report progress against team, department, and corporate goals.Create and maintain project timelines for key activities and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies.Create and maintain program-specific risk assessment dashboards and management framework.Manage R&D and regulatory policy meetings where projects will be discussed (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership may be required).Provide project management support for cross functional meetings including program planning, key action items, and progress on deliverables.  qualifications: Skills: At least 7 years' experience in project or program management; a minimum of two years' experience managing teams and team operations.Pharma/biotech industry experience required, including at least 1 year in Regulatory Affairs and/or policy.Work experience in regulatory policy, or project or program management; a minimum of two years' experience managing teams and team operations desired.Thorough understanding of the regulatory environment is a bonus.Regulatory agency experience, or experience in an industry trade organization is ideal but not an absolute prerequisite.Experience with MS Office and MS Project Online, or similar scheduling software, required or proven skill at adapting to new software/technology. Exposure to electronic document management system(s) (EDMS) and registration tracking systems helpful.The candidate should possess the ability to work as part of an interdisciplinary team spread across different time zones, have strong organizational skills, excellent interpersonal and communication (written and verbal) skills and understanding of biotech/pharmaceutical industry and nomenclature.Strong attention to detail. Education: Bachelor's or Master's degree in biology or other life sciences discipline.Project Management Professional would be helpful.  skills: Biology, Regulatory Affairs Operations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: San Rafael, California job type: Contract salary: $74.76 - 87.95 per hour work hours: 8 to 4 education: Bachelors   responsibilities: Duties: Support the Global R&D and Regulatory Policy Team in the following policy activities: Monitor, review and inform stakeholders on recently published global regulatory policies and guidance documents impacting drug development - and of treatments for rare diseases and advanced therapies in particular.Provide project management support to the policy team in generation of comments on draft guidance's.Contributing as needed to all types of internal reporting (ad hoc memos, weekly summaries, highlights, digests etc.)If required, representing Company on trade association calls and meetings, and generate minutes for the benefit of the global head or regional leads.If required, attending external scientific and regulatory conferences, typically virtually, ensuring key intelligence and highlights are shared with the team and the rest of the organization.Supporting the preparation and follow-up of internal meetings with stakeholders and SMEs.Updating the team's trackers, engagement maps and SharePoint.Monitoring and documenting progression of the team objectives and key results (OKRs).Track Team memberships and involvement in policy trade associations and organizations.Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.Lead certain policy cross-functional meetings including minutes and action items.Provide strategic logistical support for managing policy calendars and deliverables.Develop and manage internal policy publications.Develop and manage dashboards for policy team initiatives.Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.Manage Trade Association List and Memberships including main contacts.Document project milestones/deliverables and report progress against team, department, and corporate goals.Create and maintain project timelines for key activities and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies.Create and maintain program-specific risk assessment dashboards and management framework.Manage R&D and regulatory policy meetings where projects will be discussed (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership may be required).Provide project management support for cross functional meetings including program planning, key action items, and progress on deliverables.  qualifications: Skills: At least 7 years' experience in project or program management; a minimum of two years' experience managing teams and team operations.Pharma/biotech industry experience required, including at least 1 year in Regulatory Affairs and/or policy.Work experience in regulatory policy, or project or program management; a minimum of two years' experience managing teams and team operations desired.Thorough understanding of the regulatory environment is a bonus.Regulatory agency experience, or experience in an industry trade organization is ideal but not an absolute prerequisite.Experience with MS Office and MS Project Online, or similar scheduling software, required or proven skill at adapting to new software/technology. Exposure to electronic document management system(s) (EDMS) and registration tracking systems helpful.The candidate should possess the ability to work as part of an interdisciplinary team spread across different time zones, have strong organizational skills, excellent interpersonal and communication (written and verbal) skills and understanding of biotech/pharmaceutical industry and nomenclature.Strong attention to detail. Education: Bachelor's or Master's degree in biology or other life sciences discipline.Project Management Professional would be helpful.  skills: Biology, Regulatory Affairs Operations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • cambridge, massachusetts (remote)
    • contract
    • $60 - $90 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Cambridge, Massachusetts job type: Contract salary: $60 - 90 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Reporting to the Sr. Director of PVQA Quality, R&D Quality (RDQ), the Senior Manager/ Associate Director, PV Quality, will be a key contributor in growing and shaping the company's global R&D Quality Program (GCP/GLP/GVP/CSV). Primarily focusing on PV Quality, the Associate Director will assist and contribute to building RDQ's presence globally, aid in the establishment and execution of PV Quality, support the company's R&D activities both locally and globally. Support Health Authorities Inspections (e.g., MHRA, EMA etc.) and provide oversight of the Pharmacovigilance Quality audit program (e.g., Affiliate/ Vendor/Process Audits, etc.) partnering with RDQ Program Leads. This role will also support other R&D Quality GxP disciplines (GCP, GLP, and CSV) including proactive quality support, identification and conduct of audits, support of Health Authority Inspections and contributions to Regulatory Intelligence activities. The appointee will proactively partner with local R&D operational functions and teams to create a quality culture within the company and help reach a sustained state of inspection readiness. Participate in the development of Pharmacovigilance System support of global R&D activities in the region.Proactively partner with members of global and regional Research and Development organizations to support the successful and compliant execution of R&D activities.Develop and/or provide input in the development of RDQ Quality Audit Schedules and Annual Audit Plans.Provide QA consultation support for CSPV, RA and Medical Affairs/ Medical InformationAssist in the strategic direction for the global and regional program for audits (e.g., Affiliate/ Vendor/Process Audits, etc.) that integrate into the global R&D Quality program and manage the program utilizing an innovative, risk-based approach.Lead complex audits including planning, execution and reporting, and provide guidance to company staff to ensure the proposed corrective actions received from the auditees are appropriate.Provide leadership to interdisciplinary audit teams for complex systems/process audits.Proactively identify and report systematic issues as well as opportunities for process improvements.Provide education, guidance and/or training for PV functional areas.Participate in Regulatory Authority inspections (GVP, GCP, GLP) including inspection preparation training and support; actively support during the inspection and provide input and review of responses to inspection observations and regulatory agency questions resulting from inspections.Participate in compliance projects and initiatives.Contribute to the continuing development of a quality culture at the company.  qualifications: BS/BA, MS or PhD and a minimum of 12, 10, 9 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization.10+ years' experience in Pharmacovigilance QA in a global environment.Strong knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and regulations and local legislation.Experience with Device Vigilance, EU and FDABasic knowledge of relevant FDA, EU, ICH GCP guidelines, and local/regional GVP regulations/legislation.Experience working with CROs, vendors, and relationship management preferred.Excellent auditing skills and ability to communicate significant observations to internal and external business partners in a sound and factual manner.Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.Strong leadership skills with ability to effectively organize and execute tasks.Ability to work both independently and in a team environment.Excellent analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.Excellent communication and presentation skills, both verbal and written.Ability to influence and negotiate effective solutions, excellent interpersonal skills.Ability to manage multiple projects in a fast-paced environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.  skills: Pharmacovigilance, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), ICH Regulations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Cambridge, Massachusetts job type: Contract salary: $60 - 90 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Reporting to the Sr. Director of PVQA Quality, R&D Quality (RDQ), the Senior Manager/ Associate Director, PV Quality, will be a key contributor in growing and shaping the company's global R&D Quality Program (GCP/GLP/GVP/CSV). Primarily focusing on PV Quality, the Associate Director will assist and contribute to building RDQ's presence globally, aid in the establishment and execution of PV Quality, support the company's R&D activities both locally and globally. Support Health Authorities Inspections (e.g., MHRA, EMA etc.) and provide oversight of the Pharmacovigilance Quality audit program (e.g., Affiliate/ Vendor/Process A