Sr. Quality Specialist, Clinical Quality Job at Baptist Health (Florida) (Jacksonville Beach)

Sr Clinical Research Data Specialist

Works in partnership with the primary point of contact to provide high quality, ...

Location

United States of America , Rochester

Salary:

24.91 - 34.87 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s degree Required
2 years of relevant experience Required
or equivalent combination of education and experience Required
Skill in completing assignments accurately and with attention to detail Required
Ability to understand and follow standard research protocols and procedures Required
Ability to process and handle confidential information with discretion Required
Possesses a working knowledge of key processes that encompass clinical trials (e.g., Regulatory and Finance), and how these processes are impacted by clinical trial data Required
Commitment to the University’s core values Required
Ability to work independently and/or in a collaborative environment Required
Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and Good Documentation Practices (GDP) Required

Job Responsibility

Assists in conducting quality checks of data accuracy with data source records as assigned
Perform data entry and verification tasks
Provides custom programming, statistical analysis, reporting and presentation graphics
Prepare and transfer data for analysis
Supports the implementation of custom, research project-specific data workflow solutions for data collection, management, reporting and analytics
Adheres to defined application development life-cycle practices
Consults with user departments and sites to assess data preparation and management needs, program design and testing
package selection and use of systems, software and equipment
Partners with the primary point of contact to provide data status reports and ensures protocol data objectives are scheduled appropriately
Answers a broad range of data clarifications for each study

Parttime

Process and Procedural Document Specialist, Sr. Manager

Parexel FSP is hiring a Process and Procedural Document Specialist, Sr. Manager ...

Location

Argentina; Brazil; Mexico , Remote; Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

A minimum of a BA or BS is required, advanced degree in relevant field desirable. Degree or professional certification in process design or change management, or equivalent experience
A minimum 5-8 years of experience in design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical). Demonstrated process development expertise
Ability to manage multi-phase moderately complex projects with multiple contributors/collaborators, facilitate cross functional global or enterprise teams, optimize subject matter involvement, and interacts at all levels in a matrix environment. Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
strong planning and multi-tasking skills
Ability to lead by example, demonstrating the sponsor’ values and effectively implement strategies through influence and persuasion
Demonstrate ability to adapt to changing situations and work well under pressure
Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project)
tools for process design and mapping
and systems for document management, publishing, communication, and learning management
Understanding of the fundamentals of electronic publishing of procedural documents

Job Responsibility

Lead a matrix team comprised of global and/or local subject matter experts, business process owners, and key stakeholders, with minimal assistance, in the development, revision, process mapping, process enhancements, implementation and maintenance of process quality standards and procedural documentation (policies, SOPs and associated documents) for approximately 10,000 colleagues across the sponsor’ clinical, medical, safety, regulatory and enterprise quality management system global processes
Function as a key subject matter expert in the document management model, quality management system, and quality standards. Providing advice and recommendations to global and local colleagues on process enhancement and continuous improvement project teams. provide strategic recommendations regarding process design, documentation development, change management and supporting systems by understanding the business, organization and associated responsible roles
Plan and manage process development projects to address the full life cycle: requirements and policy setting
process design, documentation and training development and delivery
change management planning and deployment
and transition to an oversight system that incorporates performance monitoring and continuous improvement once the new/revised process is fully operational
Applies knowledge and understanding of global regulations in a GxP environment and produces processes and related documentation that meets regulatory requirements, supports corporate compliance, is inspection ready and is designed with operational effectiveness in mind and contains measurable controls where applicable
Identifies areas of training focus and collaborate closely with training developers on training strategies and plans
Contribute to compliance and audit/inspection readiness strategies and plans
Participate in regulatory inspections, external PV license partner audits, and other internal audits by being the liaison for documentation requests and responding to findings

(Sr.) Biopharmaceutical Specialist –Northern District, GMBU

The (Sr.) Biopharmaceutical Specialist is responsible for driving brand strategi...

Location

Taiwan , Taipei

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree or above
Minimum 3 years of sales experience in medical centers/RHs.
Minimum 1 year of Bone promotion experience
Skill and knowledge of territory planning, sales analysis, and sales excellence
Possess a high level of business ethics, integrity and professionalism and the ability to ensure those standards
Excellent communication skills and interpersonal skills
Good command of written and spoken English is preferred

Job Responsibility

Achieves sales targets for assigned accounts across Taipei and Taoyuan territories, including major medical centers and regional hospitals
Deliver scientific information and key message on the product including therapeutic indication, disease states and latest clinical data
Collaborates with manager to implement agreed POA in line with marketing strategy
Identifies and establishes high quality customer relationships and internal collaboration
Organize and implement scientific events to efficiently deliver product information
Knows in-depth knowledge of the product(s), market, stakeholders, and competitors
Works within agreed budgets
Lives the Amgen Values
Support other activities as the need arises by the manager
Align with all relevant company policies, procedures, and work practices

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Sr RCM Specialist

As the Senior RCM Specialist, you will partner with business leaders to improve ...

Location

United States

Salary:

24.93 - 31.17 USD / Hour

ATI Physical Therapy

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or suitable equivalent
5 years of healthcare experience in clinical or office setting
3 years of healthcare revenue cycle experience
Offshore revenue cycle vendor experience
Excellent in Microsoft Office applications, capable of creating detailed analyses using pivot tables and other formulas/features within Excel
Strong attention to detail
Ability to prioritize and manage multiple tasks simultaneously
Excellent interpersonal and communication skills
Must have excellent organizational skills and ability to prioritize and coordinate workload

Job Responsibility

Partner with business leaders to improve and deliver positive change throughout all revenue cycle processes
Collaborate with the RCM supervisor, RCM Sr. Mgr./Mgr. to review the quality, efficiency, and productivity of vendor partners
Work to improve the accuracy and effectiveness of revenue cycle processes through leading account audits, data analysis, training sessions, and team/vendor meetings
Maintain ATI’s policies and procedures as it relates to focused area within the revenue cycle
Assist in the summarizing of audit data to identify process improvement opportunities and creating Service Level Agreement (SLA) quality reporting
Provide ongoing monitoring of standards by conducting audits
Perform timely reviews of patient accounts and remittances for denials to determine root cause
Provide subject matter guidance to ATI team members and offshore vendor partner teams
Prepare, schedule, and lead collaboration/training sessions
Monitor KPI & SLA metrics

Fulltime

Sr. Etrif Specialist

As a Trial Master File (TMF) Specialist II at ICON, you will ensure the accuracy...

Location

United States , Raleigh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences, healthcare, or a related field
2+ years of experience in clinical trial operations or document management, with a focus on Trial Master File processes
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills
Proficiency in electronic document management systems and an understanding of regulatory requirements related to TMF
Willingness to travel as required (approximately 5%)

Job Responsibility

Managing the quality and integrity of the TMF by ensuring timely and accurate document uploads and metadata management
Collaborating with cross-functional teams to identify and resolve discrepancies in TMF documentation
Conducting regular audits of the TMF to ensure compliance with regulatory requirements and internal procedures
Providing training and support to team members on TMF best practices and document management systems
Generating reports and metrics to track TMF status and provide insights for continuous improvement

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Sr. QA Specialist - Ops

The Sr. QA Specialist – External Operations will work with other departments to ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Ability to Travel 10%

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process

Fulltime

Sr. QA Specialist - Ops

The Sr. QA Specialist – Team Lead will work with other departments to ensure the...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Ability to Travel 10%

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participate in the management review process

Fulltime

Sr Director, Medical Affairs

The Senior Director, UCAN Medical Affairs guides strategic and operational initi...

Location

United States , Deerfield

Salary:

224000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD, or equivalent scientific/clinical doctorate)
10+ years of experience in Medical Affairs, Clinical, or Scientific roles within medical devices, pharmaceuticals, or combination products
Proven leadership of downstream and field-based medical organizations across complex portfolios
Deep understanding of medical governance, compliance, and scientific engagement in regulated environments
Applicants must be authorized to work for any employer in the U.S.
We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Own and complete the downstream Medical Affairs strategy across Infusion Systems, IV Solutions, Clinical Nutrition, and Pharmacy products, aligned to regional and global medical objectives
Convert upstream medical strategy, clinical data, and evidence generation plans into tactical downstream medical plans that support launches, line extensions, lifecycle management, and in-market optimization
Ensure scientific and medical differentiation is clearly articulated and appropriately embedded across customer-facing medical activities
Lead and develop Field Medical teams (e.g., MSLs, clinical specialists) supporting downstream portfolios, ensuring consistent implementation, scientific rigor, and compliant HCP engagement
Coordinate Key Opinion Leader (KOL) strategy, including identification, engagement planning, and insight generation across therapy areas
Guide planning and execution of advisory boards, investigator meetings, educational forums, and non-promotional scientific exchanges
Responsible for scientific communication strategies supporting downstream portfolios, including data dissemination, congress strategy, and educational initiatives
Ensure accurate, balanced, and compliant communication of clinical evidence to internal and external collaborators
Collaborate with Medical Information, Clinical Development, and Global Medical teams to maintain uniformity in scientific narratives
Serve as the senior downstream medical partner to Commercial, Downstream Marketing, Sales, Training, Market Access, and Commercial Operations

What we offer

Medical and dental coverage starting on day one
Basic life insurance
Accident insurance
Short-term disability insurance
Long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs

Fulltime

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Sr. Quality Specialist, Clinical Quality

Job Description

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