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 (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

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

Customer Assistant II

Location

United States , Amherst

Salary:

26.06 - 29.33 USD / Hour

Massachusetts Municipal Association

Expiration Date

Until further notice

Requirements

High school degree or equivalent PLUS one to three years of experience in accounting, bookkeeping, or cash handling
OR any equivalent combination of related education and experience that demonstrates the ability to successfully perform the responsibilities of the position

Job Responsibility

Perform a full range of complex procedural accounting and clerical duties associated with computation, reconciliation and posting to accounts for town collection areas (e.g., Water and Sewer, Parking)

Fulltime

Care Assistant - Days

Are you ambitious? Do you want something else? Are you looking for new energy? W...

Location

United Kingdom , Poynton

Salary:

12.75 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

No previous experience or qualifications needed
Enhanced DBS check in relation to Children and Adults required

Job Responsibility

Support with personal care needs
Help residents take part in a wide range of special interests and activities that support their health and wellbeing such as arts and crafts, watching the footie, drama, musical evenings, gardening, shopping trips and social occasions

What we offer

Discounts on Shopping, Fashion, Days out, Travel, Entertainment and lots more
Flex Earn – Earned wage access
FREE face-to-face counselling for you and your family
Staff recognition award ceremonies
£30 voucher available every month for the nominated Employee of the month
Opportunities for training and career progression
Salary Sacrifice Pension scheme
Blue Light Card – up to 50% discount across 100’s of retailers
Access to a FREE eye test and discounted glasses
Cashback card – save up to £500 annually

Fulltime

DPW Highway Equipment Operator

The town of Littleton is seeking qualified applicants for a full-time 40-hour/we...

Location

United States , Littleton

Salary:

24.56 - 29.54 USD / Hour

Massachusetts Municipal Association

Expiration Date

July 17, 2026

Requirements

Valid driver's license
CDL class B
Hoisting license 2B/1C minimum (or ability to obtain within 12 months)
Ability to operate heavy equipment, riding mowers, snow and ice equipment, power and hand tools
Snow and ice operations, drainage system experience and roadway construction knowledge preferred

Job Responsibility

Perform routine work assisting in all Public Works construction, maintenance and repair projects
Operate heavy equipment, riding mowers, snow and ice equipment, power and hand tools

What we offer

On call standby stipend
Winter standby stipend
Licenses and clothing stipends per union contract
Overtime available

Fulltime

!

Grant Accountant

We are looking for a detail-oriented Grant Accountant to join our team in Vernon...

Location

United States , Vernon

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience managing grant accounting activities, including budget tracking, reporting, and compliance oversight
Knowledge of government grant requirements and nonprofit accounting practices, including restricted fund management
Ability to prepare reconciliations, journal entries, and financial analyses related to grant-funded operations
Familiarity with revenue recognition principles and month-end close processes tied to grants
Proficiency with grant management and fund administration in an accounting environment
Experience working with Abila MIP or similar nonprofit accounting software
Strong analytical skills with the ability to interpret budget variances and maintain accurate financial records

Job Responsibility

Oversee grant budgets, spending activity, and funding balances to help maintain accurate financial control across active awards
Review transactions to confirm costs are properly assigned, permitted under grant terms, and aligned with applicable funding requirements
Prepare grant-specific financial schedules, account reconciliations, and supporting documentation for internal review and external reporting
Develop and submit financial reports for grantors based on required deadlines, formats, and compliance expectations
Support audit activity by organizing records, responding to documentation requests, and assisting with grant-related testing and reviews
Partner with program leaders to build grant budgets, evaluate spending trends, and explain budget-to-actual differences
Record journal entries and maintain general ledger accuracy for grant revenue, expenditures, and fund classifications
Distinguish restricted and unrestricted funding appropriately to support proper accounting treatment and financial reporting
Collaborate with development and program teams to provide financial guidance on proposals, reporting obligations, and allowable use of funds

What we offer

Medical insurance
Vision insurance
Dental insurance
Life insurance
Disability insurance
401(k) plan
Deferred compensation plan
Paid time off for vacation, personal needs, and sick time
Paid holidays

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Sr Mgr, Regulatory Affairs

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