Ra officer Job at Product Life Group

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Quality Assurance Regulatory Affairs Coordinator

Location

United Kingdom , Oxford

Salary:

30000.00 - 40000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Proactive and able to manage multiple priorities effectively
Comfortable working in a fast-paced, regulated environment
Excellent IT skills, ability to use MS Office and pick up bespoke systems with ease

Job Responsibility

Develop and deliver QARA training and inductions on core QMS processes, procedures, and requirements
Create and maintain training materials, ensuring accurate and up-to-date training records across the business
Provide administrative support to ensure regulatory affairs (RA) activities and timelines are effectively managed
Support the development, implementation, and continuous improvement of QARA strategies and the QMS
Ensure compliance with local, national, and international regulations, monitoring regulatory changes and assessing their impact

Fulltime

Assessment and Review Officer

This is a key role within our domiciliary care service, responsible for ensuring...

Location

United Kingdom , Doncaster

Salary:

27000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Level 3 Health & Social Care qualification (or equivalent)
Experience in domiciliary care, particularly within assessment, review, or quality roles (or transferable experience)
Good understanding of medication management and care documentation standards
Strong attention to detail and organisational skills
Confident communicator with a professional and empathetic approach
Ability to manage workload independently and prioritise effectively
Full UK driving licence and access to a vehicle (Essential)
A genuine commitment to delivering high-quality, person-centred care

Job Responsibility

Carrying out regular care plan and medication audits, ensuring all documentation is accurate, compliant, and up to date
Completing new care assessments and setting up care packages, including Person-Centred Plans (PCP), Personal Medication Plans (PMP), and Risk Assessments (RA)
Reviewing and updating Medication Recording Charts (MRCs) and responding to changes in prescriptions or care needs
Completing 6–8-week reviews and annual care plan reviews to ensure care reflects current needs
Responding promptly to changes in service user needs and updating plans and risk assessments accordingly
Conducting competency assessments with care staff (e.g. medication and moving & handling)
Undertaking spot checks and quality assurance reviews to maintain high standards
Supporting investigations, audits, and continuous quality improvement activity
Working flexibly across the field and office in line with service needs
Participating in an on-call schedule to support service continuity outside of standard hours

What we offer

Hybrid working – a balance of field based and office based work
Training & development – ongoing learning opportunities
Supportive team culture focused on quality and improvement
Employee wellbeing support including EAP and benefits platform
Career progression opportunities within a growing organisation
£500 Refer a friend scheme
Paid Birthday leave

Fulltime

Assessment and Review Officer

Are you passionate about ensuring people receive the right care, at the right ti...

Location

United Kingdom , Huddersfield

Salary:

27000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Level 3 Health & Social Care qualification (or equivalent)
Experience in domiciliary care, particularly within assessment, review, or quality roles (or transferable experience)
Good understanding of medication management and care documentation standards
Strong attention to detail and organisational skills
Confident communicator with a professional and empathetic approach
Ability to manage workload independently and prioritise effectively
Full UK driving licence and access to a vehicle (Essential)
A genuine commitment to delivering high-quality, person-centred care

Job Responsibility

Carrying out regular care plan and medication audits, ensuring all documentation is accurate, compliant, and up to date
Completing new care assessments and setting up care packages, including Person-Centred Plans (PCP), Personal Medication Plans (PMP), and Risk Assessments (RA)
Reviewing and updating Medication Recording Charts (MRCs) and responding to changes in prescriptions or care needs
Completing 6–8-week reviews and annual care plan reviews to ensure care reflects current needs
Responding promptly to changes in service user needs and updating plans and risk assessments accordingly
Conducting competency assessments with care staff (e.g. medication and moving & handling)
Undertaking spot checks and quality assurance reviews to maintain high standards
Supporting investigations, audits, and continuous quality improvement activity
Working flexibly across the field and office in line with service needs
Participating in an on-call schedule to support service continuity outside of standard hours

What we offer

Hybrid working
Training & development – ongoing learning opportunities
Supportive team culture focused on quality and improvement
Employee wellbeing support including EAP and benefits platform
Career progression opportunities within a growing organisation
£500 Refer a friend scheme
Paid Birthday leave

Fulltime

Regulatory Affairs Officer

Contribute to regulatory activities performed on the RA Platform/the Hub. Regula...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or higher degree in a science related field, or equivalent experience
4-6 years of experience in RA European Regulation
Good English language and grammar skills (written fluency a must, verbal fluency preferred)
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.
Excellent organizational and interpersonal skills
Ability to work well within a team
Process orientated with good attention to detail

Job Responsibility

Contribute to regulatory activities performed on the RA Platform/the Hub
Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
To contribute to the production of client administrative documents and reports to be included in regulatory submissions
Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
Systems Management and Administration
Document and track regulatory submissions and regulatory authority approval
Gain regulatory authority approval
Provide regulatory support to clients and associate companies
Liaise with sponsor head-office and affiliate departments on regulatory issues
Liaise with external regulatory authorities as required

Fulltime

Regulatory Affairs Specialist

A Specialist profile will ensure efficient project execution, better quality out...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or higher degree in a science related field, or equivalent experience
7-8 years of EU RA technical and project management experience
Good English language and grammar skills (written fluency a must, verbal fluency preferred)
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.
Excellent organizational and interpersonal skills
Ability to work well within a team

Job Responsibility

Contribute to regulatory activities performed on the RA Platform/the Hub
Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
To contribute to the production of client administrative documents and reports to be included in regulatory submissions
Support for Initial MA application, all kind of LCM activities
Act as (Single) Point of Contact and oversee clients’ portfolios
Cross-functional co-ordination
Communication with external vendors
Communication/Co-ordination with client and participate in client’s meeting, preparing MoM etc
Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
Systems Management and Administration

Fulltime

Clinical Project Manager - Early Phase Trials

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United States , Remote

Salary:

125000.00 - 138000.00 USD / Year

Parexel

Expiration Date

Until further notice

Requirements

2 years of Project Management experience with Parexel or 3 to 5 years in related fields
Experience as a Functional Team Leader or in coordinating clinical trials
Knowledge of ICH-GCP and pharmaceutical industry regulations
Proficiency in MS-Office products
Bachelor’s degree in a science-related field or equivalent work experience

Job Responsibility

Lead cross-functional teams to deliver high-quality and patient-focused clinical trials
Collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets
Manage the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices
Own the sponsor relationship and manage sponsor communication
Serve as the central point of contact and escalation for functional teams
Proactively communicate project progress, risks, and solutions to sponsors and internal teams
Lead regular meetings with sponsors and project teams to ensure objectives are met
Review relevant materials and attend strategy meetings
Prepare for Bid Defense and develop project management strategies
Attend Bid Defense and handover meetings

What we offer

Annual performance-based bonus plan
Annual salary review
Additional total rewards incentives
Paid time off
401k match
Life insurance
Health insurance
Other benefit offerings in accordance with the terms of applicable plans

Fulltime

Initiation Clinical Research Associate

Location

Brazil

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Communicator
Detail-oriented
Flexible
Organized
Problem-solver
Self-starter
Demonstrate strong problem-solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work

Job Responsibility

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Support on request country specific feasibility and/or site pre-qualification and qualification activities, which may include: Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA) and any amendments
May conduct remote Qualification Visits (QVs)
Liaison with stakeholders to understand Clinical Site Agreements (CSA) timelines
Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems
Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (Site SIV Readiness/Greenlight Documents) and any updated or amended regulatory documentation
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy

What we offer

Flexible work arrangements

Portfolio & Strategic Planning Analyst

We are seeking an experienced Portfolio & Strategic Planning Analyst to support ...

Location

United States , Chantilly

Salary:

Not provided

Arcfield

Expiration Date

Until further notice

Requirements

Must possess and be able to maintain a TS/SCI clearance with Polygraph
BS 10-12, MS 8-10, PhD 5-7, or equivalent experience in quantitative analysis, financial analysis, social sciences, or a closely related field
Knowledge of strategic planning and resource management processes
Knowledge of program planning and execution processes
Knowledge of business resource planning practices and cost analysis methodologies
Knowledge of quality assurance procedures to ensure data integrity and timeliness of data
Knowledge of economic and accounting principles and practices
Knowledge of program risk assessment principles and processes
Ability to apply analytic, diagnostic, and quantitative techniques sufficient to identify, evaluate, and recommend to managers substantive solutions to resolve interrelated quantitative analytical problems and issues
Knowledge of IC strategic planning and resource management processes and tools

Job Responsibility

Serve as a member of a team of professionals assigned to develop and execute multiple budgets and spend plans, and collaborate with other teams within this program to advance the PMO's mission
Identify and reduce overlapping investments to manage funds more efficiently
Effectively manage SLAs, MOUs, and MOAs with sponsor service providers and other cost agreements, as necessary
Apply business resource planning practices and cost analysis methodologies
Apply economic, accounting, and program risk assessment principles and practices
Interact with multiple external stakeholders at various employee levels, to include Senior Executive Leaders
Research complex topics at both the conceptual and moderately detailed levels and provide readout briefings
Participate in Resource Authority (RA) Forums, Technical Authority (TA) Forums, Business Working Group (BWG), and ad hoc meetings, summits, and conferences, as appropriate
Create and provide briefings, presentations, and other appropriate content using Microsoft Office products such as Excel, PowerPoint, and Word
Provide technical documentation for agenda topics

Fulltime

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Ra officer

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Ra officer

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