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Regulatory and Start Up Specialist at Precision for Medicine
, , Australia - Full Time
Skills Needed
Regulatory Affairs, Clinical Trials, Communication, Organizational Skills, Project Management, Data Management, Ethics Committee Interaction, Clinical Operations, Site Activation, Patient Information, Informed Consent, Translation Coordination, Budget Negotiation, Feasibility Assessment, Regulatory Compliance, Audit Readiness
Specialization
Candidates should have a bachelor's degree in life sciences or a related field, with at least one year of experience in regulatory or start-up roles. Strong communication skills and proficiency in electronic systems are also required.
Store Manager - Liquorland Rozelle at Coles Group
Rozelle, New South Wales, Australia - Full Time
Skills Needed
Retail Management, Customer Service, Team Leadership, Inventory Management, Sales Goals, Administrative Tasks, Communication Skills, Rsa Certification
Specialization
Candidates should have experience in fast-paced retail or hospitality environments and possess strong administrative skills. An RSA certification is required or must be obtained.
Experience Required
Minimum 2 year(s)
Rehabilitation and Recovery Worker at Wellways Australia
Wagga Wagga City Council, New South Wales, Australia - Full Time
Skills Needed
Mental Health Support, Community Services, Data Entry, Recovery Planning, Family Support, Natural Supports, Self Management Skills, Risk Assessments, Referral Documentation
Specialization
Candidates should have relevant qualifications or experience in supporting individuals with mental illness. A current driver's license, police check, and various certifications are also required.
Cleaning - Leading Hand | Bathurst at Sodexo
Bathurst, New South Wales, Australia - Full Time
Skills Needed
Customer Service, Team Leadership, Time Management, Cleaning, Organizational Skills, Interpersonal Skills, Safety Awareness, Communication Skills, Computer Literacy, Attention To Detail, Stamina, Positive Attitude, Flexibility, Cohesive Teamwork, Adhoc Cleaning, Cleaning Policies
Specialization
Candidates should have experience leading a small team and possess strong organizational and customer service skills. A high level of safety awareness and the ability to work effectively in a team are also essential.
Experience Required
Minimum 2 year(s)
Cleaning - Leading Hand | Bathurst at Sodexo
Bathurst, New South Wales, Australia - Full Time
Skills Needed
Customer Service, Time Management, Team Leadership, Organizational Skills, Interpersonal Skills, Safety Awareness, Communication Skills, Cleaning Methods, Detail Cleaning, Rostering Support, Positive Attitude, Stamina, Teamwork, Flexibility, Work Ethic, Computer Literacy
Specialization
Candidates should have experience leading a small team and possess strong organizational and customer service skills. A high level of safety awareness and the ability to work effectively in a team are also essential.
Experience Required
Minimum 2 year(s)
Admin and Customer Service Officer at Toll Holdings Limited Canada
Wallangarra, Queensland, Australia - Full Time
Skills Needed
Administration, Customer Service, Logistics Support, Documentation, Data Entry, Reporting, Communication, Organizational Skills, Time Management, Attention To Detail, Teamwork, Microsoft Office, Erp Platforms, Wms Platforms
Specialization
Candidates should have at least 3 years of experience in administration, customer service, or logistics support, with relevant qualifications being highly regarded. Strong communication skills and proficiency in Microsoft Office and ERP/WMS platforms are essential.
Experience Required
Minimum 2 year(s)
Campaign Manager - Branded Content at Nine
Sydney, New South Wales, Australia - Full Time
Skills Needed
Campaign Management, Digital Operations, Analytical Skills, Organizational Skills, Time Management, Interpersonal Skills, G Suite, Microsoft Suite, Excel, Programmatic Trading
Specialization
Candidates should have a Bachelor’s degree and proven experience in digital operations and campaign management. Strong skills in GSuite and Microsoft products, particularly Excel, are essential.
Experience Required
Minimum 2 year(s)
Culture and Communications Partner at Lendi Group
Sydney, New South Wales, Australia - Full Time
Skills Needed
Internal Communications, Employee Engagement, Corporate Communications, Public Relations, Editorial Craft, Writing, Editing, Ai Literacy, Content Production, Event Planning, Stakeholder Engagement, Measurement And Analytics, Social Media Management, Channel Ownership, Communication Strategy, Team Collaboration
Specialization
Candidates should have over 4 years of experience in internal communications or related fields, with strong writing and editorial skills. Familiarity with tools like Confluence and Slack is valued, along with the ability to use AI tools effectively.
Experience Required
Minimum 5 year(s)
Store Associate - TK Maxx Eastland at TJX Companies
, , Australia - Full Time
Skills Needed
Customer Service, Team Player, Fast Paced Environment, Product Presentation, Retail Experience, Hospitality Experience, Can Do Attitude, Flexibility
Specialization
Retail or hospitality experience is preferred but not essential. Candidates should be team players with a positive attitude and a passion for customer service.
Coordinator - Fitness and Services at Hume City Council
Melbourne, Victoria, Australia - Full Time
Skills Needed
Occupational Health & Safety, Equal Employment Opportunity, Staff Leadership, Program Development, Customer Service, Fitness Software, Communication Skills, Stakeholder Liaison, Operational Management, Financial Management, Safety Management, Group Fitness Classes, Gym Operations, Policy Development, Technological Improvements, Budgeting
Specialization
Candidates should have tertiary qualifications related to Physical Education or a relevant fitness certification, along with current First Aid and CPR qualifications. Experience in leisure centre operations and staff management is essential.
Experience Required
Minimum 5 year(s)
Coordinator - Fitness and Services at Hume City Council
Melbourne, Victoria, Australia - Full Time
Skills Needed
Occupational Health & Safety, Equal Employment Opportunity, Staff Leadership, Program Development, Customer Service, Fitness Software, Communication Skills, Stakeholder Liaison, Operational Management, Financial Management, Safety Management, Fitness Qualifications, First Aid, Cpr, Technological Improvements, Budgeting
Specialization
Candidates should have tertiary qualifications related to Physical Education or Fitness, along with current First Aid and CPR certifications. Experience in leisure centre operations and staff management is also required.
Experience Required
Minimum 5 year(s)
enrolled nurse (en) | summer hill at Randstad
Summer Hill, New South Wales, Australia - Full Time
Skills Needed
Computer Competency, Disabilities
Qualification
Diploma
senior project manager / construction manager at Randstad
MCC, Victoria, Australia - Full Time
Skills Needed
N/A
Qualification
Graduate
technical consultant advice to 130k at Randstad
SCBD, New South Wales, Australia - Full Time
Skills Needed
Strategy, Superannuation, Legislation, Training
Qualification
Graduate
Experience Required
Minimum 3 year(s)
junior it administrator - cbd at Randstad
SCBD, New South Wales, Australia - Full Time
Skills Needed
Communication Skills
Qualification
Graduate
Experience Required
Minimum 1 year(s)
site engineer i telecommunications at Randstad
MES, Victoria, Australia - Full Time
Skills Needed
Communication Skills, Design, Telecommunications
Qualification
Graduate
customer service representative - airport at Randstad
Brisbane Airport, Queensland, Australia - Full Time
Skills Needed
N/A
Qualification
Graduate
Experience Required
Minimum 2 year(s)
contant centre team leader aps6 at Randstad
Penrith, New South Wales, Australia - Full Time
Skills Needed
N/A
Qualification
Graduate
customer service at Randstad
Warriewood, New South Wales, Australia - Full Time
Skills Needed
N/A
Qualification
Graduate
sourcing specialist aps6 - maroochydore at Randstad
Sunshine Coast, Queensland, Australia - Full Time
Skills Needed
Contract Management, Excel, It, Outlook, Microsoft Applications, Procurement
Specialization
Accounting, Business, Commerce
Qualification
Graduate
Regulatory and Start Up Specialist at Precision for Medicine
, , Australia -
Full Time


Start Date

Immediate

Expiry Date

15 Feb, 26

Salary

0.0

Posted On

17 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Clinical Trials, Communication, Organizational Skills, Project Management, Data Management, Ethics Committee Interaction, Clinical Operations, Site Activation, Patient Information, Informed Consent, Translation Coordination, Budget Negotiation, Feasibility Assessment, Regulatory Compliance, Audit Readiness

Industry

Pharmaceutical Manufacturing

Description
Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues we grow we are seeking a Regulatory and Start Up Specialist to join our growing team. Essential functions of the job include but are not limited to: Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. Customize country/site specific Patient Information Sheet and Informed Consent Form. Responsible for/facilitates the translation and co-ordination of translations for documents. Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF May support the clinical team performing Pre-Study Site Visits. The ideal candidate will have: Minimum Required: Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Other Required: Strong communication and organizational skills. Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. Fluency in English. Preferred: Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. Experience using milestone tracking tools/systems. Ability to prioritize workload to meet deadlines Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science. We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Responsibilities
The Regulatory and Start Up Specialist is responsible for ensuring site activation readiness and managing submissions to regulatory bodies. This includes preparing clinical trial application forms, maintaining project plans, and collaborating with various teams to ensure compliance with local regulations.
Regulatory and Start Up Specialist at Precision for Medicine
, , Australia - Full Time
Skills Needed
Regulatory Affairs, Clinical Trials, Communication, Organizational Skills, Project Management, Data Management, Ethics Committee Interaction, Clinical Operations, Site Activation, Patient Information, Informed Consent, Translation Coordination, Budget Negotiation, Feasibility Assessment, Regulatory Compliance, Audit Readiness
Specialization
Candidates should have a bachelor's degree in life sciences or a related field, with at least one year of experience in regulatory or start-up roles. Strong communication skills and proficiency in electronic systems are also required.
Store Manager - Liquorland Rozelle at Coles Group
Rozelle, New South Wales, Australia - Full Time
Skills Needed
Retail Management, Customer Service, Team Leadership, Inventory Management, Sales Goals, Administrative Tasks, Communication Skills, Rsa Certification
Specialization
Candidates should have experience in fast-paced retail or hospitality environments and possess strong administrative skills. An RSA certification is required or must be obtained.
Experience Required
Minimum 2 year(s)
Rehabilitation and Recovery Worker at Wellways Australia
Wagga Wagga City Council, New South Wales, Australia - Full Time
Skills Needed
Mental Health Support, Community Services, Data Entry, Recovery Planning, Family Support, Natural Supports, Self Management Skills, Risk Assessments, Referral Documentation
Specialization
Candidates should have relevant qualifications or experience in supporting individuals with mental illness. A current driver's license, police check, and various certifications are also required.
Cleaning - Leading Hand | Bathurst at Sodexo
Bathurst, New South Wales, Australia - Full Time
Skills Needed
Customer Service, Team Leadership, Time Management, Cleaning, Organizational Skills, Interpersonal Skills, Safety Awareness, Communication Skills, Computer Literacy, Attention To Detail, Stamina, Positive Attitude, Flexibility, Cohesive Teamwork, Adhoc Cleaning, Cleaning Policies
Specialization
Candidates should have experience leading a small team and possess strong organizational and customer service skills. A high level of safety awareness and the ability to work effectively in a team are also essential.
Experience Required
Minimum 2 year(s)
Cleaning - Leading Hand | Bathurst at Sodexo
Bathurst, New South Wales, Australia - Full Time
Skills Needed
Customer Service, Time Management, Team Leadership, Organizational Skills, Interpersonal Skills, Safety Awareness, Communication Skills, Cleaning Methods, Detail Cleaning, Rostering Support, Positive Attitude, Stamina, Teamwork, Flexibility, Work Ethic, Computer Literacy
Specialization
Candidates should have experience leading a small team and possess strong organizational and customer service skills. A high level of safety awareness and the ability to work effectively in a team are also essential.
Experience Required
Minimum 2 year(s)
Admin and Customer Service Officer at Toll Holdings Limited Canada
Wallangarra, Queensland, Australia - Full Time
Skills Needed
Administration, Customer Service, Logistics Support, Documentation, Data Entry, Reporting, Communication, Organizational Skills, Time Management, Attention To Detail, Teamwork, Microsoft Office, Erp Platforms, Wms Platforms
Specialization
Candidates should have at least 3 years of experience in administration, customer service, or logistics support, with relevant qualifications being highly regarded. Strong communication skills and proficiency in Microsoft Office and ERP/WMS platforms are essential.
Experience Required
Minimum 2 year(s)
Campaign Manager - Branded Content at Nine
Sydney, New South Wales, Australia - Full Time
Skills Needed
Campaign Management, Digital Operations, Analytical Skills, Organizational Skills, Time Management, Interpersonal Skills, G Suite, Microsoft Suite, Excel, Programmatic Trading
Specialization
Candidates should have a Bachelor’s degree and proven experience in digital operations and campaign management. Strong skills in GSuite and Microsoft products, particularly Excel, are essential.
Experience Required
Minimum 2 year(s)
Culture and Communications Partner at Lendi Group
Sydney, New South Wales, Australia - Full Time
Skills Needed
Internal Communications, Employee Engagement, Corporate Communications, Public Relations, Editorial Craft, Writing, Editing, Ai Literacy, Content Production, Event Planning, Stakeholder Engagement, Measurement And Analytics, Social Media Management, Channel Ownership, Communication Strategy, Team Collaboration
Specialization
Candidates should have over 4 years of experience in internal communications or related fields, with strong writing and editorial skills. Familiarity with tools like Confluence and Slack is valued, along with the ability to use AI tools effectively.
Experience Required
Minimum 5 year(s)
Store Associate - TK Maxx Eastland at TJX Companies
, , Australia - Full Time
Skills Needed
Customer Service, Team Player, Fast Paced Environment, Product Presentation, Retail Experience, Hospitality Experience, Can Do Attitude, Flexibility
Specialization
Retail or hospitality experience is preferred but not essential. Candidates should be team players with a positive attitude and a passion for customer service.
Coordinator - Fitness and Services at Hume City Council
Melbourne, Victoria, Australia - Full Time
Skills Needed
Occupational Health & Safety, Equal Employment Opportunity, Staff Leadership, Program Development, Customer Service, Fitness Software, Communication Skills, Stakeholder Liaison, Operational Management, Financial Management, Safety Management, Group Fitness Classes, Gym Operations, Policy Development, Technological Improvements, Budgeting
Specialization
Candidates should have tertiary qualifications related to Physical Education or a relevant fitness certification, along with current First Aid and CPR qualifications. Experience in leisure centre operations and staff management is essential.
Experience Required
Minimum 5 year(s)
Coordinator - Fitness and Services at Hume City Council
Melbourne, Victoria, Australia - Full Time
Skills Needed
Occupational Health & Safety, Equal Employment Opportunity, Staff Leadership, Program Development, Customer Service, Fitness Software, Communication Skills, Stakeholder Liaison, Operational Management, Financial Management, Safety Management, Fitness Qualifications, First Aid, Cpr, Technological Improvements, Budgeting
Specialization
Candidates should have tertiary qualifications related to Physical Education or Fitness, along with current First Aid and CPR certifications. Experience in leisure centre operations and staff management is also required.
Experience Required
Minimum 5 year(s)
enrolled nurse (en) | summer hill at Randstad
Summer Hill, New South Wales, Australia - Full Time
Skills Needed
Computer Competency, Disabilities
Qualification
Diploma
senior project manager / construction manager at Randstad
MCC, Victoria, Australia - Full Time
Skills Needed
N/A
Qualification
Graduate
technical consultant advice to 130k at Randstad
SCBD, New South Wales, Australia - Full Time
Skills Needed
Strategy, Superannuation, Legislation, Training
Qualification
Graduate
Experience Required
Minimum 3 year(s)
junior it administrator - cbd at Randstad
SCBD, New South Wales, Australia - Full Time
Skills Needed
Communication Skills
Qualification
Graduate
Experience Required
Minimum 1 year(s)
site engineer i telecommunications at Randstad
MES, Victoria, Australia - Full Time
Skills Needed
Communication Skills, Design, Telecommunications
Qualification
Graduate
customer service representative - airport at Randstad
Brisbane Airport, Queensland, Australia - Full Time
Skills Needed
N/A
Qualification
Graduate
Experience Required
Minimum 2 year(s)
contant centre team leader aps6 at Randstad
Penrith, New South Wales, Australia - Full Time
Skills Needed
N/A
Qualification
Graduate
customer service at Randstad
Warriewood, New South Wales, Australia - Full Time
Skills Needed
N/A
Qualification
Graduate
sourcing specialist aps6 - maroochydore at Randstad
Sunshine Coast, Queensland, Australia - Full Time
Skills Needed
Contract Management, Excel, It, Outlook, Microsoft Applications, Procurement
Specialization
Accounting, Business, Commerce
Qualification
Graduate
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