Medical Information Junior Associate Job at Product Life Group (Melbourne)

Junior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Malaysia , Petaling Jaya

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in a Scientific or Technical Discipline
0-2 years’ experience in an industry-related environment
Works effectively within a team environment
Works within broad project guidelines as directed by the project Technical Lead or Project Manager
With the guidance of the project Technical Lead or Project Manager, demonstrates the ability to prioritize work to achieve specified project outcomes
Capitalizes on opportunities to improve performance and seeks feedback from the project Team Lead and colleagues
Applies information provided by the project Team Lead or senior colleagues to complete assigned project activities
Produces quality work that meets the expectations of Project Lead and the client
Completes assigned activities within project scope and objectives under the direction of the Project Lead
Identifies project and internal issues to senior colleagues and Project Lead

Job Responsibility

Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions
Provide basic regulatory affairs services including preparing submission packages Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
Develop a familiarity with current global regulatory submission standards
Develop a familiarity with departmental standard operating procedures and work instructions
(Regulatory Affairs only) Under supervision provide support to currently marketed products

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Fulltime

Clinical Research Associate

Location

United States , Houston

Salary:

Not provided

Establishment Labs

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field such as life sciences, engineering, pharmacy, business, clinical research, or a related discipline
Good Clinical Practices certification
Knowledge in Systematic literature search Zotero/Mendeley
Medical Device Regulation
Advanced English C1 scored
7+ years of experience on similar roles
Microsoft Office suite (Word, Excel, PowerPoint, Planner, etc.)

Job Responsibility

Coordinate and oversee clinical trial activities throughout the study lifecycle
Provide strategic guidance and oversight, mentoring junior staff and coordinating with management
Develop and maintain clinical trial documentation
Advanced clinical support, including document creation for product registration and statistical analysis of clinical trials
Create, implement and administer methods and procedures to enhance operations, as appropriate
Provide clinical feedback and knowledge to Regulatory Affairs in the creation of documents required for products registration and technical file (Clinical Evaluation Report)
Oversee clinical trial operations and site performance
Clinical trials reports creation
Submission package readiness for Ethics Committees approval
including clinical protocols, design case report forms, patient and investigator brochure, informed consent form, among others

Fulltime

Senior Clinical Documentation Specialist (CDI)

Our client is seeking an experienced Senior Clinical Documentation Specialist (C...

Location

United States , Tampa

Salary:

35.00 - 50.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Associate’s Degree in Nursing, Health Information Management (HIM), or a related healthcare field
Minimum 6 years of acute care Clinical Documentation Improvement (CDI) experience
Strong understanding of ICD-10-CM/ICD-10-PCS coding, Medicare/Medicaid/commercial payer guidelines, and clinical documentation improvement practices
Proven ability to independently develop compliant provider queries and collaborate directly with providers
Experience with at least two of the following: Optum 360 eCAC, Cerner EHR, Vizient
Strong inpatient CDI background
Strong written and verbal communication skills
Critical thinking and problem-solving ability
Ability to work independently in a remote environment

Job Responsibility

Review medical records for documentation quality, completeness, and accuracy
Identify gaps, conflicting documentation, and unspecified diagnoses
Develop compliant provider queries to improve documentation specificity
Ensure documentation accurately reflects severity of illness and risk of mortality
Collaborate directly with physicians and clinical staff through meetings, rounding, Zoom calls, phone calls, and email
Assist with provider education related to documentation improvement practices
Utilize clinical judgment, NLP tools, and CDI software platforms to support documentation review
Partner with HIM coding teams to support accurate reimbursement and reporting outcomes
Support onboarding and mentoring of junior CDI team members
Participate in operational and leadership-driven CDI initiatives and special projects

What we offer

100% remote work with flexible scheduling within EST business hours (Monday–Friday)
Strong long-term conversion potential for candidates in approved states
Collaborative, accountable, and supportive team environment
Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage options
401k plan with company match and full vesting upon eligibility
Paid time off, sick time, and paid company holidays
Opportunities for professional growth, mentoring, and special project involvement

Fulltime

Senior Clinical Research Associate

Senior Clinical Research Associate - Neurovascular - Midwest/Central ICON plc i...

Location

United States , TEXAS, MISSOURI, BLUE BELL, WISCONSIN, CHICAGO

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science
3 years of monitoring required (medical device, pharma, CRO industry)
The ideal candidate will have medical device monitoring experience- however, pharma monitoring experience will be considered
Neuro or Neurovascular monitoring experience a plus
Located in Central/Midwest region (willing to travel to west coast and east coast as needed)
In-depth knowledge of FDA regulations and ICH/GCP guidelines
Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly
Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams
Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely
Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment

Job Responsibility

independently monitors trials either onsite or remotely, ensuring compliance with protocols, ICH-GCP guidelines, ICON and/or customer SOPs, and applicable regulatory requirements
supports complex studies, contributes to operational excellence, and serves as a mentor to junior staff, while maintaining site readiness for audits and inspections

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

Junior Benefits Administrator

As a Benefit Verification Specialist your primary responsibility is to verify th...

Location

India , Chennai

Salary:

Not provided

iTech

Expiration Date

Until further notice

Requirements

Prior experience in Enrollment, Benefits verification, RCM Proficiency in using computer software (MS office) and well known with computer shortcuts
Good communication skills, both verbal and written, with the ability to effectively interact with diverse stakeholders
Attention to detail and accuracy in verifying insurance information and documenting records
Ability to multitask, prioritize workload, and work efficiently in a fast-paced environment
Knowledge of medical terminology, insurance terminology, and healthcare billing practices
Commitment to maintaining confidentiality and adhering to regulatory requirements
Customer service-oriented mindset with a focus on delivering high-quality support to patients and healthcare providers
Experience: 0 to 2 Years
Qualification: Any Graduate
Gender: Male candidate

Job Responsibility

Obtain and review insurance information provided by patients or healthcare providers
Verify the eligibility, coverage details, and any limitations or restrictions associated with the patient's insurance plan
Contact insurance companies via phone, email, or online portals to verify benefits, including coverage for specific medical services, medications, and procedures
Clarify any discrepancies or issues related to coverage and escalate complex cases as necessary
Explain insurance coverage details, co-payments, deductibles, and other relevant financial information to patients
Assist patients in understanding their insurance benefits and potential out-of-pocket expenses
Maintain accurate and up-to-date records of insurance verification activities in electronic health record (EHR) systems or other designated databases
Document communication with insurance companies, patients, and healthcare providers
Keep abreast of changes in insurance policies, regulations, and reimbursement procedures
Attending training sessions or workshops to enhance knowledge of insurance verification processes and industry updates

Fulltime

Principal Physician, Patient Safety

Location

India

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
Expertise in drug safety and the drug development process
Demonstrated success in technical proficiency and scientific creativity
Ability to work on complex problems requiring in-depth evaluation
Ability to exercise judgment within broadly defined practices and policies
Good presentation and verbal/written communication skills
Good interpersonal skills
Client focused approach to work
Demonstrated ability to balance technical expert responsibilities with people management duties when assigned
Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps

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
Communicating and discussing issues related to review process with Line Manager/Project Leader/Designee
Interacting with internal and external stakeholders for resolving issues
Attending and/or presenting at client/cross functional meetings along with other stakeholders
Working as Subject Matter Experts (SMEs)
Assisting the Project Lead/Functional Lead for audits and inspections, Act as a Subject Matter Expert during Audits/inspections
Provides inputs for process improvements
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
Function as pharmacovigilance representative/safety scientist

Fulltime

Senior Application Administrator - Workday Integrations

This position is responsible for the design, development, testing and debugging ...

Location

United States , Miramar

Salary:

Not provided

Memorial Healthcare System

Expiration Date

Until further notice

Requirements

Associates: Information Technology
Minimum 5 years of relevant experience
Additional Education Info: Information Technology, Computer Science, or related field. Relevant work experience may substitute for education requirement

Job Responsibility

Review and recommend how new technology may fit IT strategy
Responds to escalated issues involving complicated technical troubleshooting
Provides expert and creative solutions by building new user requirements, functionality, or enhancements
Prepares documentation of system capabilities, output requirements, input data acquisition, programming techniques, and controls
Performs market and industry research to support business application enhancements
Manages technical components such as application environment, underlying technology, servers, Operating Systems, network, databases, firewall, load balancer, etc.
Manages business projects requiring high level of subject matter expertise
Maintains server hardware and software
Leads planning of business application development and deployment
Leads or oversees an entire business application module or system, providing mentorship to junior administrators

Fulltime

Senior Engineering Group Leader - System Engineering

Location

United States , Bedford

Salary:

160000.00 - 190000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Must have a bachelor’s degree in Electrical Engineering, Systems Engineering, Biomedical Engineering or closely related field
Advanced degree is preferred
Must have a proven track record in a management or leadership role with a demonstrated record managing and/or developing systems engineering team capability (7-10 years experience) (team of 5+ ppl strongly desired)
Strong project engineering/management capability with expertise in Waterfall and Agile methodologies
Proven ability to plan and deliver complex programs (resource allocations, workload balancing, WBS, PI planning) while leading and developing high performing team
Experience leading the development of test strategies, exploratory evaluations, and formal design verification from early concept through submission readiness
Must have experience in design requirements and risk management, with the ability to translate identified and emerging risks into actionable verification strategies and detailed test plans, driving risk mitigation to closure in collaboration with cross-functional teams
Partner with Quality Engineering and Regulatory teams to support audit readiness and contribute to the Design History File (DHF)
Should have experience in estimating and plan verification and validation activities across the development lifecycle
Specify detailed and traceable test cases based on system requirements and risk analysis

Job Responsibility

Reporting to the Functional Manager, responsible for assigning and overseeing the practical use of technology across multiple programs assuring the proper use of common architecture
Receives requirements specifications from the Project/Program Managers and prepares specifications to design, develop or integrate technologies required to make a product and its specific derivatives
Responsible for all Functional Specifications and Theory of Operation documents, including schematics, design layouts, detail and assembly drawings, bill of materials, associated analytical data and any implementation documents
May act as group leader or lead engineer on a major program, perform independent development, and be responsible for a number of smaller projects
Technical authority that helps guide the decision-making process for Coagulation programs
Credible leader who can influence with strong organizational and prioritization skills with a results-oriented mindset
Leads the definition of the instrument risk and V&V strategy driving alignment across cross-functional teams in R&D
Leads with hands-on approach in the development of design verification plans and authoring protocols that map requirements to objective test methods with defined acceptance criteria
Manages a team responsible for planning and execution of the integration strategy together with Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering, Coag Analytical, and Reagent Development
Partner with the Project Manager to define the Design Control Schedule and resources (FTE, Instruments, Tools)

What we offer

Medical, dental, and vision insurance
401k plan retirement benefits with an employer match
Paid vacation and sick leave
Performance-based bonus

Fulltime

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Medical Information Junior Associate

Job Description

Job Responsibility

Requirements

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