Sr Mgr, Regulatory Affairs Job at Baxter (Deerfield)

Sr Mgr, Regulatory Affairs

A Senior Manager of Global Regulatory Affairs leads the development and executio...

Location

United States , Deerfield

Salary:

152000.00 - 209000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree or country equivalent in a scientific discipline
Master's and/or PhD will be preferred
Minimum of 7-year experience in RA
Expert Regulatory knowledge
Sound basis of Scientific (Training/ Communications) knowledge
Management skills
Ability to oversee multiple projects in a matrix team environment
Excellent oral and written communication and presentation skills
Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
Technical and management skills

Job Responsibility

Serves as the Global Regulatory Lead for Baxter’s hemostat and sealant product(s) registered as biologic/combination products
Provide technical and strategic input for regulatory decisions aligned with business strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
Assess impact of new regulations and provide feedback
Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
Act as primary contact for meetings with regulatory authorities including planning and leadership
Maintain appropriate communication within the RA function, with Global Marketing, and with other functions primarily at the project team level
Plan and manage complex projects and prioritize workload
Initiate, manage and maintain operational activities in support of new and existing marketing authorizations

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Sr Mgr, Regulatory Affairs

A Senior Manager of Global Regulatory Affairs leads the development and executio...

Location

United States , Deerfield

Salary:

152000.00 - 209000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree or country equivalent in a scientific discipline
Master's and/or PhD will be preferred
Minimum of 7-year experience in RA
Expert Regulatory knowledge
Sound basis of Scientific knowledge
Management skills
Ability to oversee multiple projects in a matrix team environment
Excellent oral and written communication and presentation skills
Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
Technical and management skills

Job Responsibility

Serves as the Global Regulatory Lead for Baxter's hemostat and sealant product(s)
Provide technical and strategic input for regulatory decisions
Identify & prioritize key areas of risk
Monitor, evaluate, and interpret all applicable regulatory requirements
Assess impact of new regulations
Evaluate technical and scientific information
Act as primary contact for meetings with regulatory authorities
Maintain appropriate communication within the RA function
Plan and manage complex projects
Initiate, manage and maintain operational activities

What we offer

Medical and dental coverage starting day one
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Biostatistics Sr Mgr

As a Biostatistics Sr. Manager, you will lead study-level statistical deliverabl...

Location

United States

Salary:

154104.15 - 208493.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research
Bachelor’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs
Plan and execute statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Implement, manage and support standards, technical quality and consistent approaches in strategy, study design and statistical analysis
Knowledgeable of developments in the field of statistics in drug development (innovative trial design) and Amgen’s statistical policies, procedures and strategies
Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for product
Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listing shells, submission data file specifications, and other key study-related documentation
Collaborate cross-functionally to deliver robust, valid and scientifically rigorous analysis results in Table, Figure and Listings (TFLs), Flash Memos (FM), Clinical Study Reports (CSRs), clinical publications, and other communications
Serve as the GBS lead on the Clinical Study Team leadership team to execute clinical trials according to the protocol, performing risk assessments and ensuring quality data collection and alignment between data collection and study objectives
Contribute to clinical publications, regulatory filing documents, reimbursement documents and other communications for product or study
Provide statistical consultancy, training, and advice within Amgen

What we offer

Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans
flexible work models where possible

Fulltime

Biostatistics Sr Mgr

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States

Salary:

154104.15 - 208493.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Statistics/Biostatistics or related subject with high statistical content and at least 2 years of Biostatistics experience
Master's degree in Statistics/Biostatistics or related subject with high statistical content and at least 4 years of Biostatistics experience
Bachelor's degree in Statistics/Biostatistics or related subject with high statistical content and at least 6 years of Biostatistics experience
Associate's degree and 10 years of experience
High school diploma / GED and 12 years of experience

Job Responsibility

Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs
Implementing, managing and supporting standards, technical quality and consistent approaches in strategy, study design and statistical analysis
Planning and executing statistical contributions to protocols, Flash Memos and Clinical Study Reports (CSRs)
Providing input for clinical publications and regulatory filing documents
Leading all aspects of work performed by study statisticians
Performing statistical and exploratory analysis of studies/projects and developing conclusions and recommendations
Anticipating and communicating resource and quality challenges that could impact results or timelines
Solid understanding of regulatory guidelines in drug development
Staying current in developments in the field of statistics in drug development (innovative trial design) and Amgen's statistical policies, procedures and strategies
Contributing to process improvements and operational efficiencies

What we offer

Comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

New

Medicaid Pricer Regulatory Analyst

Location

India , Hyderabad

Salary:

Not provided

Zelis

Expiration Date

July 31, 2026

Requirements

Interest in developing knowledge of reimbursement methodologies and applicable regulatory frameworks
Strong attention to detail with the ability to accurately interpret written material
Effective written and verbal communication skills with the ability to convey information clearly and concisely
Strong multitasking and time-management skills in deadline-driven environments
Strong critical thinking skills to evaluate issues, identify solutions, and support data-driven decision-making
Working knowledge of Microsoft Excel with experience using formulas, lookups, and data comparison tools
Working knowledge of public and private healthcare payment systems, medical claims, standard claim coding, claim editing, contracting, and provider networks
Working knowledge of MS SQL Server Studio a plus
4 years of relevant experience or equivalent combination of education & work within healthcare payer or provider
Knowledge of healthcare reimbursement methodologies, claim coding and acceptable billing practices

Job Responsibility

Perform basic research on Medicaid regulations, state bulletins, and published fee schedules under the guidance of senior team members
Summarize regulatory findings and assist in interpreting requirements for internal use
Assist in maintaining pricing logic and configuration by performing routine updates and data entry tasks
Help draft or update procedural documentation, SOPs, and reference materials
Contribute to the creation of user story components (e.g., requirements outlines, rule summaries)
Use Excel or internal tools to conduct comparisons, calculations, and data-driven validation
Support the preparation of sample claims and expected outcomes for testing and QA
Participate in system testing by executing test cases and documenting results
Assist in identifying potential issues or discrepancies in pricing outputs and escalating to senior analysts
Collaborate with internal teams—including Development, QA, and Client Services—to clarify questions and support project work

Fulltime

New

Operations Support Rep II

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States , Rochester

Salary:

19.04 - 26.63 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

High School diploma or equivalent and 2 years of related work experience, including one year in the Facilities Customer Service Department required
Or equivalent combination of education and experience
Customer Service, Control Center, and Emergency response experience required
Skills with typing/keyboarding required
Familiarity with Microsoft Office, and the ability to utilize multi-line telephones and other office equipment, including copiers, scanners, and printers required
Ability to articulate professionally required
Proven ability to react to stressful situations in a calm and professional manner required
National Incident Management System (NIMS) certification within 1 year required

Job Responsibility

Provides vital dispatch and communication support for the entire University and its affiliates
Responds to and manages high-volume inbound inquiries via phone, email, web, and electronic interfaces
Troubleshoots and provides resolutions to issues with critical and non-critical inquiries regarding equipment and operating systems
Creates and dispatches work orders
Monitors multiple, distinct building automated alarm systems
Provides communication, dispatches, provides basic technical support, and creates National Incident Management System (NIMS) based documentation for all University emergencies
Responds to service calls and requests by answering telephone, e-mail, and web-based, including social media, service call requests from members of the University community and non-University community
Troubleshoots response to the nature of the request, with special attention to critical situations
Determines appropriate responses based on the nature of the request, with special attention to critical and urgent situations
Creates and dispatches work orders to appropriate personnel and departments depending on the level and severity of the request

Fulltime

New

Sales Development Representative

As a Sales Development Representative, you will manage both inbound & outbound l...

Location

Australia , North Sydney

Salary:

70000.00 - 90000.00 AUD / Year

Workday

Expiration Date

Until further notice

Requirements

2+ years proven track record of achieving & exceeding sales targets in a inbound and / or outbound BDR role
You don't wait for permission to act. Whether you've led sports teams, held leadership roles in academia, or initiated movements, we want to hear from those who instinctively lead from the front
You are self-motivated, driven, and hungry for success. Whether it's in sales, sports, or any endeavor, your commitment to learning, growing, and achieving is paramount
You excel at building relationships quickly and aren't shy about connecting with others
Our core values are the foundation of our culture, guiding our daily interactions and motivating high performance with mutual respect and unwavering trust

Job Responsibility

Manage both inbound & outbound leads
Play a key role in driving our sales pipeline by identifying, qualifying, and delivering qualified opportunities to our Account Executives across ANZ
Work closely with our regional marketing teams to execute campaigns and provide valuable feedback
Collaborate with Account Executives to develop effective account engagement strategies
Generate high-value activity
Conduct in-depth research to understand industry drivers
Communicate professionally with C-Suite executives to articulate the value of our solutions

What we offer

High Earning Potential
Clear Career Pathways
Industry-Leading Mentorship
Comprehensive Benefits
Continuous Learning
Competitive Compensation
Collaborative Culture
Diverse and Supportive Team

Fulltime

New

Payroll Analyst

🚀 Join the Future of Commerce with Whatnot! Whatnot is the largest live shoppi...

Location

United States , New York; Los Angeles; San Francisco; Seattle

Salary:

95000.00 - 105000.00 USD / Year

Whatnot

Expiration Date

Until further notice

Requirements

5 - 7+ years of US payroll processing experience
3 + years of Hands-on experience with Workday Payroll
Multi-state payroll expertise
Strong knowledge of US tax regulations and wage laws
Experience with payroll audits and reconciliations
Advanced Excel skills
ADP SmartCompliance

Job Responsibility

Process biweekly US payroll in Workday
Validate earnings, deductions, taxes, and garnishments
Ensure compliance with federal, state, and local regulations
Manage multi-state payroll processing and tax allocations
Maintain compliance with IRS and state tax regulations
Support internal and external payroll audits
Prepare and validate year-end reporting (W-2s)
Troubleshoot payroll errors and resolve discrepancies along with Sr Global Payroll Analyst
Partner with HR and Benefits to ensure accurate data integration
Develop and maintain payroll reports and calculated fields

What we offer

Generous Holiday and Time off Policy
Health Insurance options including Medical, Dental, Vision
Work From Home Support
Home office setup allowance
Monthly allowance for cell phone and internet
Care benefits
Monthly allowance for wellness
Annual allowance towards Childcare
Lifetime benefit for family planning, such as adoption or fertility expenses
Retirement

Fulltime

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Sr Mgr, Regulatory Affairs

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