Drug Authorization Specialist Job at Daley and Associates (Boston)

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...

Location

United States , Thousand Oaks

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of Manufacturing support experience
Bachelor’s degree and 4 years of Manufacturing support experience
Associate’s degree and 8 years of Manufacturing support experience
High school diploma / GED and 10 years of Manufacturing support experience

Job Responsibility

Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
Serve as document author, owner, reviewer, or data verifier
Maintain documentation to accurately reflect operational practices and regulatory requirements
Support implementation of new processes, equipment, and major initiatives within Drug Product operations
Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
Develop and implement data-driven solutions to improve yield, reliability, and compliance
Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire
Support timely investigation and resolution of manufacturing deviations

What we offer

A 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
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Patient Safety Associate II/Patient Safety Specialist - Japanese

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel...

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Sound knowledge of drug safety and the drug development process
Knowledge of and ability to interpret and apply global safety regulations
Experience in data analysis and evaluation of safety data
Good presentation skills
Analytical and problem-solving skills
Clear understanding of the regulatory submission process
Proficient in database/literature searches
Excellent interpersonal skills
Excellent verbal / written communication skills
Excellent organizational and prioritization skills

Job Responsibility

Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
Assist in development of project specific safety procedures, workflows and templates
Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
Delegate work as appropriate to Drug Safety Assistants
Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
Mentoring new recruits in the team, if required
Archiving the source documents and relevant emails as required

New

Drug Authorization Specialist

Drug Authorization Specialist – Boston, MA. We are seeking candidates for a Drug...

Location

United States , Boston

Salary:

20.00 - 22.00 USD / Hour

Daley and Associates

Expiration Date

Until further notice

Requirements

BS in Health Science / Healthcare-related field of study (Preferred)
0-2 years of relevant work experience, including medical billing, denials, healthcare/business administration, health insurance, medical policy/chart review, nursing, and/or other allied health fields
Strong communication skills
Strong Microsoft Office suite experience
Need to be in the New England area

Job Responsibility

Perform pre-registration of new patients by making/receiving patient calls, collecting and documenting patient demographics, financial, and other relevant personal information
Verify patient identification
Update changes to patient insurance and/or demographic information as needed
Manage referral and authorization information as assigned
Communicate regularly with physicians and other medical providers regarding clinical clarifications
Document daily activities in a timely and accurate manner in the hospital information system

Fulltime

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Senior Engineer I- General Civil

Senior-level team member contributing to high-profile projects and shaping the d...

Location

United States , Las Cruces

Salary:

93000.00 - 105000.00 USD / Year

Souder Miller & Associates

Expiration Date

Until further notice

Requirements

Bachelor’s degree in appropriate engineering or science
Minimum ten years of experience post-graduation
Professional/Occupational licensure required
Must have a valid driver's license and able to pass the drug test
Candidates must be authorized to work in the United States without current or future sponsorship

Job Responsibility

Prepare and monitor project budgets
has overall responsibility for the profitability of assigned projects
Responsible for monitoring and managing work-in-process, accurate and timely client billings, outstanding accounts receivable and collection efforts on projects
Responsible for project and/or office technical group(s) schedules and timely completion of projects
Serve as a senior project design specialist on complex projects of any size and as a designated client contact or client manager
Supervise and monitor client relationship strategies
is the primary client contact for assigned clients
Coordinate and review pricing, estimating, scoping, and marketing strategies for proposed projects of any size or fee
In coordination with TS Director/Manager, develop and review contract agreements for assigned projects
Executes agreements with value-limited signatory authority

What we offer

Health, Dental, Vision, 401K Retirement Plan, Employee Stock Options (ESOP), Life/ADD Insurance, Short & Long-Term Disability, Voluntary Insurance, Flexible Spending Account, Dependent Care
Generous PTO, flexible work schedules, wellness initiatives
Tuition/Student Loan reimbursement program, professional dues, and opportunities for advancement within the company

Fulltime

Operations Compliance Specialist

Reporting to the Inspection Readiness Lead, the Operations Compliance Specialist...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

2+ years’ experience in technical writing and compliance
Proficient in data analytics, data visualization
Working knowledge in Regulations, GMP, GDP
2+ working within a regulated healthcare industry including a role in capacity of quality and compliance
Strong verbal, written and oral communication skills
Able to work independently and be flexible to changing priorities

Job Responsibility

Manage the authoring & drafting of all types of Manufacturing Operations documentation
Specifications & associated forms in conjunction with the various departmental subject matter experts (SME)
Support document updates and manage timelines for cross functional Projects
Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents
Organise & Facilitate Document Round Table meetings with cross functional teams as required
Mange and build Quality Veeva QMS metrics for Manufacturing Operations
Coach & Train colleagues in Documentation System & GDP queries
Support manufacturing operations on meeting deadlines on Veeva QMS records
Update compliance procedures and processes
Generate Reports/Metrics & analyze trends as required including but not limited to: Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics, Doc Tracker Metrics, RFT Metrics

Quality Assurance Manager

The Quality Assurance (QA) Manager provides site-specific quality oversight and ...

Location

United States , Fenton

Salary:

80000.00 - 90000.00 USD / Year

Strive Compounding Pharmacy

Expiration Date

Until further notice

Requirements

High School Diploma or GED
Minimum of five (5) years experience in a quality or manufacturing department within a pharmaceutical, medical device, or allied health science environment
Proven experience in aseptic operations and working in regulated environments
Strong knowledge of pharmaceutical quality assurance practices, including deviation management, CAPA, change control, and documentation review
Ability to analyze and interpret data, identify trends, and recommend preventive actions
Strong organizational, communication, and problem-solving skills
Proficiency with Microsoft Office Suite and quality management systems (QMS)

Job Responsibility

Supervise the site Quality Assurance team, including task assignment, workload prioritization, timecard management, performance reviews, coaching, and discipline as needed
Lead QA candidate interviews and oversee onboarding, training, and competency development
Conduct routine QA team meetings and cross-department quality huddles
Train QA personnel to ensure proficiency in documentation, review, and compliance expectations
Conduct regular reviews of compounding, production, and cleaning documentation (batch records, cleaning logs, inventory sheets) for accuracy and completeness
Verify and reconcile all labeling to ensure control and accountability
Review temperature monitoring and Building Management System (BMS) alarms to verify timely investigation and resolution
Confirm that product test results meet specifications prior to release
Review documentation for media fill and process validation activities
Approve equipment calibration, preventive maintenance, and certification records to ensure adherence to schedules and standards

What we offer

Employer paid healthcare coverage available after 30 days of employment
Choice of an FSA/HSA
Voucher for new hire scrubs (if applicable)
Parental leave
401(k) plan with matching contributions
Weekends and holidays off
FREE COMPOUNDED MEDS to employees and immediate family members

Fulltime

Talent Acquisition Specialist

KDM Engineering is seeking a Talent Acquisition Specialist to lead full-cycle re...

Location

United States , Chicago

Salary:

65000.00 - 80000.00 USD / Year

KDM Engineering

Expiration Date

Until further notice

Requirements

Strong understanding of recruiting processes, with the ability to interpret and explain technical job requirements
Experience recruiting engineering or technical roles preferred
background in distribution engineering or related fields is a plus
Working knowledge of modern sourcing techniques, including social media and Boolean search
Experience using Paylocity or similar HRIS/ATS platforms
Excellent communication, organization, and time-management skills
Must be willing to comply with all pre-employment screening requirements, including drug testing, background checks, reference verification, and education/employment verification
Must be legally authorized to work in the United States
Valid driver’s license required

Job Responsibility

Manage full life-cycle recruitment for internal corporate positions
Partner with hiring managers to identify current and future hiring needs, including technical requirements for engineering roles
Source passive and active candidates using job boards, professional networks, social media, and Boolean search techniques
Draft and maintain clear, accurate job descriptions and post to appropriate recruiting platforms
Screen applicants for qualifications, experience, and role alignment
Coordinate and conduct phone, video, and in-person interviews
Present qualified candidates and hiring recommendations to hiring managers
Facilitate offer letters, employment paperwork, and pre-employment processes
Maintain accurate records in the applicant tracking system and provide timely communication to candidates throughout the hiring process

What we offer

Positive team environment
Competitive salaries
Flexible schedules
Growth opportunities
Training and professional development
Health, dental, and vision insurance
401(k)
Life, long-term disability, and short-term disability insurances
Paid time-off
Paid holidays

Fulltime

Drug Authorization Specialist

Daley and Associates

Location:
United States , Boston

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 15, 2026

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