Medical Affairs Document Coordinator Job at MillenniumSoft Inc (Sandy)

Medical Affairs Project Coordinator

We are partnering with an innovative healthcare technology organization to ident...

Location

United States , Palo Alto

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor's degree required
Previous experience in project coordination, operations, or administrative support within healthcare, biotech, pharmaceutical, or related industries preferred
Familiarity with artificial intelligence tools or AI-supported business processes is a plus
Strong organizational skills with the ability to manage multiple priorities in a deadline-driven environment
Excellent written and verbal communication skills
Strong analytical mindset with the ability to monitor workflows and identify process improvements
Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook
Experience with project management platforms and document management systems
Background supporting vendor processes, meeting coordination, documentation workflows, and budget tracking preferred

Job Responsibility

Partner directly with senior leadership to provide day-to-day operational and project support for the medical affairs function
Coordinate timelines, deliverables, and progress tracking across multiple ongoing projects and strategic initiatives
Prepare, organize, and maintain reports, presentations, project materials, and key documentation
Manage department document repositories, ensuring accurate version control, organization, and accessibility
Support implementation and day-to-day use of project tracking systems, digital tools, and workflow processes
Facilitate communication between internal teams and cross-functional stakeholders to support project alignment
Coordinate team meetings, including scheduling, agenda preparation, documentation, and follow-up on action items
Process financial and administrative tasks such as purchase requisitions, purchase orders, invoicing, and vendor coordination
Assist with vendor communications and help track deliverables to ensure project timelines are met
Support resource planning, budget tracking, and administrative oversight for team initiatives

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Medical Affairs Project Coordinator

We are partnering with an innovative healthcare technology organization to ident...

Location

United States , Palo Alto

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor's degree required
Previous experience in project coordination, operations, or administrative support within healthcare, biotech, pharmaceutical, or related industries preferred
Familiarity with artificial intelligence tools or AI-supported business processes is a plus
Strong organizational skills with the ability to manage multiple priorities in a deadline-driven environment
Excellent written and verbal communication skills
Strong analytical mindset with the ability to monitor workflows and identify process improvements
Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook
Experience with project management platforms and document management systems
Background supporting vendor processes, meeting coordination, documentation workflows, and budget tracking preferred

Job Responsibility

Partner directly with senior leadership to provide day-to-day operational and project support for the medical affairs function
Coordinate timelines, deliverables, and progress tracking across multiple ongoing projects and strategic initiatives
Prepare, organize, and maintain reports, presentations, project materials, and key documentation
Manage department document repositories, ensuring accurate version control, organization, and accessibility
Support implementation and day-to-day use of project tracking systems, digital tools, and workflow processes
Facilitate communication between internal teams and cross-functional stakeholders to support project alignment
Coordinate team meetings, including scheduling, agenda preparation, documentation, and follow-up on action items
Process financial and administrative tasks such as purchase requisitions, purchase orders, invoicing, and vendor coordination
Assist with vendor communications and help track deliverables to ensure project timelines are met
Support resource planning, budget tracking, and administrative oversight for team initiatives

What we offer

medical, vision, dental, and life and disability insurance
401(k) plan

Medical Affairs Oncology/Specialty Manager

Office-based activities: Develop and execute the medical strategy for GSK’s Onco...

Location

Ukraine , Kiev

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Medical degree (MD), advanced scientific degree (PhD) with relevant oncology clinical experience is an advantage
5–10+ years’ experience in Oncology Medical Affairs, clinical development, or related functions
Experience managing cross‑functional projects
Strong scientific credibility and clinical judgement
Strong verbal and written communication skills
ability to tailor complex scientific information to diverse audiences
Commitment to compliance and ethical engagement
Understanding of statistical design and analysis
Effective networking and collaboration skills with demonstrated ability to influence cross-functionally
Curiosity and commitment to continuous learning and professional development

Job Responsibility

Lead development and execution of the GSK Ukraine Medical Plan aligned to global medical strategy and local needs
Provide scientific and clinical expertise on Oncology/Specialty biology, treatment paradigms, and evolving data to internal teams (Commercial, R&D, Regulatory)
Oversee clinical trial strategy and investigator-initiated studies (IIS)
Drive medical affairs activities: congress strategy, symposia, advisory boards, and scientific materials for HCPs visiting
Leverage scientific expertise and market knowledge to identify and engage HCPs, including academic and community physicians, pharmacists, nurses, and other healthcare professionals, to assess educational needs
Engage with HCPs on emerging data, clinical trials, medical unmet needs, patient barriers to access, and market dynamics
provide disease-state and product-related scientific education in a non-promotional manner
Collect and communicate medical insights across the product lifecycle to contribute to medical strategy and understand the potential impact of these insights
Interpret and communicate clinical evidence to stakeholders
translate data into clinical and payer insights

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Senior Medical Affairs Advisor, Vaccines

Reporting to the Medical Director, you will provide scientific and medical suppo...

Location

Hong Kong , Quarry Bay

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree in pharmacy, pharmacology or other relevant disciplines
Professional experience in hospitals, research or pharmaceutical industry is desirable
Project and process management: ability to manage projects and cross-functional Processes
Administrative excellence: attention to detail evident in a disciplined approach to document training, adherence to SOPs, forecast to spend tracking, metrics, etc.
Organizational skills and able to work independently
Fluent spoken and written English and Chinese

Job Responsibility

Develop, lead and execute the medical strategy, tactics, and operating plan at country level for Vaccines portfolio that fully aligned with the Global, Regional and Local overall strategy goals
Prepare new product launch by generating medical insights and understand the unmet medical needs through medical-to-medical communication, advisory board and data generation
Manage investigator-initiated trial including discussion of research concept with interested researcher, coordinate internal submission and approval of study protocol, and act as a liaison between Pfizer and the researcher
Review promotional materials and customer engagement programs for scientific accuracy and adherence to the relevant policies, guidelines, local industry codes and regulatory guidelines as required
Provide disease and product training to sales and marketing colleagues when required
Establish partnership with patient organizations, professional organizations, medical societies to understand the unmet medical needs. Identify potential ways to address them with an aim to improve patients’ outcomes
Organize medical meetings and activities with KOLs to deliver cutting edge medical information of defined therapeutic area and assigned products
Conduct medical educational meetings to introduce new concepts to help HCPs to improve patients’ outcome and advance their research capability
May speak at medical communication meetings at national and regional levels

Fulltime

New

Senior Regulatory Affairs Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Degree in Pharmacy preferred
+3 years of experience in pharmaceutical, medical device or health industry
Experience in regulatory affairs or relevant discipline is preferred
Solid understanding of drug development
Good knowledge of National Drug Regulations and Procedures
English Proficiency
Good communication skill for external and internal interaction
Good computer literacy skills, comfortable working with database

Job Responsibility

Achieve timely & successful product registration in accordance with corporate & local strategies
Collect any information on new regulations and guidelines and share it in local RA team
Ensure compliance with company regulatory policies, regulations and procedures
Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-functional team meeting
Manage all regulatory tasks & projects including attaining, maintaining product licenses and operations licenses for assigned portfolio on behalf of company as required by local regulations
Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
Develop local registration plans in alignment with local business and global regulatory strategy
Monitor progress of submission & coordinate timely responses to all questions from health authorities
Be compliant with Corporate Policies, Regulations & Procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures
Management of regulatory submissions to support clinical trial activities

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

New

Medical Device Regulatory Administrator

Exciting Opportunity: Medical Device Regulatory Administrator. Are you a highly ...

Location

United Kingdom , Gosmore

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Previous experience in an administrative, document control, compliance, quality, or regulatory support role
Strong organisational skills with the ability to manage multiple priorities simultaneously
Excellent verbal and written communication skills
High levels of accuracy and attention to detail
Confidence using Microsoft Office applications, particularly Word and Excel
Experience working with databases and electronic record systems
The ability to work independently while collaborating effectively with multiple teams

Job Responsibility

Managing and recording customer feedback relating to product quality and safety matters
Coordinating communication between internal departments, customers, distributors, and external partners
Maintaining document control systems, including SOPs, work instructions, and other controlled documents
Supporting the preparation of reports and data summaries used for monitoring product performance and quality trends
Reviewing regulatory standards, specifications, and guidelines, and assisting with gap analysis activities
Supporting artwork review and approval processes
Conducting document checks prior to manufacturing activities to ensure compliance requirements are met
Maintaining databases and ensuring records remain accurate, complete, and up to date

Fulltime

New

Patient Access Liaison - Site of Care - Rare Disease

The Patient Access Liaison (PAL) is a field-based patient access and reimburseme...

Location

United States of America , Chicago

Salary:

158394.00 - 222256.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of patient services and/or access and reimbursement experience OR Bachelor's degree and 4 years of patient services and/or access and reimbursement experience OR Associate's degree and 8 years of patient services and/or access and reimbursement experience OR High school diploma / GED and 10 years of patient services and/or access and reimbursement experience

Job Responsibility

Serve as a resource on patient access and reimbursement for infused and specialty therapies
Assist patients, caregivers, and healthcare providers in navigating insurance benefits, prior authorization requirements, and reimbursement processes
Support the identification and resolution of access challenges, including coverage questions, prior authorization barriers, and denied claims
Provide education regarding coding and billing considerations relevant to therapy access
Develop relationships with patients and caregivers through phone, virtual, and in-person engagement
Secure written or electronic patient HIPAA authorization within assigned geography
Assess individual patient needs and provide education and resources that support access to therapy
Educate patients on coverage considerations and the steps required to obtain prior authorization
Provide information regarding co-pay assistance programs, national foundations, and free drug programs when appropriate
Educate physician offices and sites of care on therapy coverage pathways and reimbursement processes

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
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

New

Sr. Compliance Quality Engineer

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Minimum of 4 years of experience in manufacturing processes, quality systems, regulatory compliance, and GMPs within Baxter or in companies producing healthcare devices
Validated knowledge of ISO 9001, ISO 13485, PMD Law, CMDR, MDSAP, CFR 21 and the Manufacturing Maturity Program (CMMI)
Validated experience in auditing systems and certification as an Internal Auditor
Knowledge and experience in Sterility Assurance
University training in Engineering (Production, Industrial, Chemical, Systems, Electrical, Electronics, Electromechanics) or related career
Equivalent experience in production environments with Quality Systems in the medical device manufacturing industry

Job Responsibility

Own the Complaints, CAPA, Risk Management, Hold and Corrective Actions systems, as well as their critical metrics and participation in local, regional and corporate forums
Implement the Internal Audit Program and follow up on corrective and preventive actions
Assess the regulatory alignment of processes and systems
Ensure they follow applicable directives and standards
Coordinate the system for change oversight, making sure changes stay in sync with regulatory requirements
Ensure evaluations of complaint samples, manufacturing investigations, and coordination with Product Surveillance within defined timeframes
Facilitate root cause analysis and ensure complete documentation in CAPA processes
Implement and maintain the risk system, assessing and controlling risks and leading residual risk
Ensure the accurate execution of the Hold process and the corrective field actions (FCA)
Maintain effective communication with productive areas and lead actions to reduce complaints

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

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Medical Affairs Document Coordinator

Job Description

Job Responsibility

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