- JOB SUMMARY
- MAJOR ACCOUNTABILITIES
- EDUCATION
- COMPETENCIES
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Nursing specialist as practical instructor
1 week ago
Nexus Innovations Lawrenceville, United StatesAre you passionate about helping people in your nursing profession and value finding joy in your work? · ▸ If a respectful work environment is important to you · ▸ If you are looking for a strong team and a positive work atmosphere · ▸ If appreciation and recognition motivate y ...
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Administrative Specialist Ii
2 days ago
State of Delaware Smyrna, United StatesThis is the second level administrative specialist work organizing and coordinating administrative activities in support of a variety of operational areas. Positions assigned to this level report to an administrator typically responsible for a program area involving several funct ...
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Registered Nurse I-iii
4 days ago
State of Delaware Smyrna, United States**Introduction**: · **Make a Difference** · **_ Now offering Recruitment and Referral Incentives at the Delaware Department of Health and Social Services (DHSS)_** · **$10,000.00 recruitment incentive for** · - **Registered Nurses** · - **Advanced Practice Nurses** · - **Nurse Co ...
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Administrative Specialist Ii
1 week ago
State of Delaware Smyrna, United States**Introduction**: · **Make a Difference with DHSS** · Our mission at the Department of Health and Social Services (DHSS) is to improve the quality of life of Delaware citizens by promoting health and well-being, fostering self-sufficiency, and protecting vulnerable populations. W ...
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ASK Staffing Smyrna, United StatesPreferably Onsite Smyrna 2x week · Clinical Development Quality Lead · Notes from HM: · Looking for an experienced Clinical Quality Assurance professional to support inspection readiness activities for key clinical program. This role will involve working cross-functionally with U ...
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NovaWorks Smyrna, United StatesDo you love being able to help people in your nursing profession and value the joy of work? · ▸ If respectful interaction in the workplace is important to you · ▸ If you are looking for a strong team and a good working atmosphere · ▸ If appreciation and recognition motivate you · ...
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IP Practice Specialist
1 week ago
Jones Day Atlanta, United StatesWe are not accepting candidate submissions from search agencies for this position. · Intellectual Property (IP) Practice Specialists work under the supervision of an attorney. Responsibilities include assisting with drafting and prosecuting patent applications, and supporting IP ...
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Right of Way Specialist
2 days ago
Environmental Consultants (ECI) Marietta, United StatesWe are currently seeking a **Right of Way Specialist** to join our team. We are looking for energetic professionals who enjoy working outdoors and value the freedom of working independently. If you enjoy a fast-paced environment and the challenges of a rewarding profession, consi ...
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General Procurement
14 hours ago
GSK Marietta, United States**Site Name**: USA - Pennsylvania - Marietta · **Posted Date**: May · Today, there are millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. GSK wants to change this. W ...
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nurse practice specialist, oncology
2 days ago
Emory Healthcare/Emory University Atlanta, GA , USA, United States**Overview** · **Heart. Soul. Expertise.** That's what defines an Emory Employee. No matter where you are in your Healthcare career, when you chose this distinguished profession, you chose to change lives. Emory Healthcare is the only health system in Georgia with four Magnet-des ...
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clinical practice specialist rn
6 days ago
Grady Health System Atlanta, GA , USA, United StatesGrady Health System offers many career paths for experienced professionals. Whether you have many years of experience or are in the early stages of your career, you can find a rewarding career at Grady · SUMMARY: · The Clinical Practice Specialist RN supports and promotes the mis ...
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Nurse Practice Specialist, Oncology
1 week ago
Emory Healthcare Atlanta, GA, United States Full timeNo matter where you are in your Healthcare career, when you chose this distinguished profession, you chose to change lives. Emory Healthcare is the only health system in Georgia with four Magnet-designated hospitals as well as the first and only in Georgia with a Magnet-designate ...
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Nurse Practice Specialist, Oncology
13 hours ago
Emory Healthcare Atlanta, GA, United StatesOverview · Heart. Soul. Expertise. That's what defines an Emory Employee. No matter where you are in your Healthcare career, when you chose this distinguished profession, you chose to change lives. Emory Healthcare is the only health system in Georgia with four Magnet-designated ...
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Nurse Practice Specialist, Oncology
1 week ago
Emory Healthcare Atlanta, GA, US, United StatesOverview: · Heart. Soul. Expertise. That's what defines an Emory Employee. No matter where you are in your Healthcare career, when you chose this distinguished profession, you chose to change lives. Emory Healthcare is the only health system in Georgia with four Magnet-designated ...
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Key Account Specialist, Immunology
4 days ago
Johnson & Johnson Atlanta, United StatesJanssen Biotech, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Key Account Specialist to support Atlanta GA & Birmingham AL territory. · **As the Key Account Specialist, you will**: · - Achieve sales goals for the Immunology portfolio of products ...
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Doctor in training
1 week ago
Spectrum Dynamics Powder Springs, United StatesPhysician in Training (m/f/d) in the field of general medicine in Powder Springs at Norderstedt · The practice for orthopedics and trauma surgery in Norderstedt offers you the opportunity to deepen your expertise in the field of general medicine through further training as a spec ...
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Accounts Payable Specialist
4 days ago
Safe-Guard Products International LLC Atlanta, United States**Job Title**: Accounts Payable Specialist (hybrid) · **Location**:US-GA-Atlanta (Sandy Springs) · **FLSA**: Exempt · **Job Overview**: · This is a high-volume, fast-paced, customer-facing position with responsibilities for processing vendor payments as well as commission and inc ...
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Specialist in Gynecology and Obstetrics
1 week ago
NebulaTech Brookhaven, United StatesPrivate practice / sexual counseling / 3D 4D ultrasound / hormone analysis / cancer prevention / pediatric and adolescent gynecology · Location: · Bavaria / Commuting area near Munich Airport · Employer: · For a client who runs their own private practice, I am currently seeking a ...
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Specialist in Radiology
1 week ago
Sapphire Enterprises Brookhaven, United StatesAre you looking for a new challenge? Then we have an exciting opportunity for you On behalf of our client, a radiology practice in the Nuremberg area, we are currently seeking a Specialist in Radiology (m/f/d) to join their team as soon as possible. akut Doc is a specialist in th ...
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Right of Way Specialist
2 days ago
Environmental Consultants (ECI) Atlanta, United StatesWe are currently seeking a **Right of Way Specialist** to join our team. We are looking for energetic professionals who enjoy working outdoors and value the freedom of working independently. If you enjoy a fast-paced environment and the challenges of a rewarding profession, consi ...
US - Quality Assurance GCP & Good Clinical Practice& - Specialist - Smyrna, United States - ASK Staffing
Description
Preferably Onsite Smyrna 2x weekClinical Development Quality Lead
Notes from HM:
Looking for an experienced Clinical Quality Assurance professional to support inspection readiness activities for key clinical program.
This role will involve working cross-functionally with UCB internal departments and external organizations, such as CROs, to resolve quality issues to ensure inspection preparedness.
Specific responsibilities will include:
Co-lead inspection preparation meetings with team with a focus on inspection preparation at the study level for a key program.
Conduct Quality Control checks of the eTMF.
Support data integrity assessments.
Support the inspection readiness of investigator sites.
Conduct inspection risk assessments for CROs and vendors.
Provide guidance on compliance and regulations and ensure study teams are following targeted SOPs during study.
Help SMEs in the development of storyboards and functional area presentations.
The ideal candidate will possess:
Knowledge and interpretation of GCP regulations and standards, with understanding of phase appropriate application of GCP expectations.
Direct experience with FDA and/or EMA or other health authority inspections of sponsor, investigator site(s), and/or CRO(s).
Self-motivated with the ability to take initiative, ownership and manage responsibilities while shifting priorities quickly under tight timelines.
Strong analytical skills, problem solving techniques, and understanding of ensuring level of effort to address observations/quality issues is commensurate with risk.
clinical development portfolio across the UCB sites and departments and provide Clinical
Development Quality input to cross functional teams dealing with complex and/or important
projects and issues
Providing mentoring and guidance to other members of the Clinical Development Quality
team, supporting the Global Head and/or Regional Heads by deputizing for them at
meetings on request, and contributing to planning and resource prioritization decisions for
Clinical Development Quality activities
Partnering with Development Solutions in driving quality into the clinical activities across
the UCB sites
Providing quality and compliance oversight as well as investigative support to UCB
activities regulated by Good Clinical Practices (GCP)
JOB DESCRIPTION
sop-af V3.0
Refer to sop-011813
Page 2 of 4
The above description is intended to describe the general content and requirements for the performance of this job. It is
not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Management has the right to
assign or reassign duties and responsibilities to this job at any time.
To lead the development of a risk mitigation program for UCB clinical programs,
prospectively identifying critical quality risk factors and their potential impact, and
developing efficient processes or solutions to manage the risks
To lead the overall Inspection Readiness process for preapproval GCP inspections or other
inspections involving the clinical programs
To support inspections and investigations conducted by international and national
authorities, including responsibility for the preparation and hosting of UCB sponsor sites for
inspections
To independently plan, coordinate and execute Clinical Development Quality activities in
accordance with the risk mitigation plans to validate the systems and processes
established to ensure subject safety and protection and to ensure that clinical trials
performed, and data are generated in compliance with international and national GCPs
As required, review and coordinate the output of trends from audits and risk analyses
prepared by colleagues, providing senior management and peers in other departments with
a summary and analyses of the comparative risks and outcomes across multiple clinical
programs
To ensure resolution of audit findings through close collaborations with the audit &
compliance team. Utilize in-depth knowledge and understanding of current business trends,
applicable regulations and quality principles, to collaborate effectively and influence
approaches to quality, and ensure work products and output are aligned with regulatory
guidelines, ICH-GCP, other applicable regulatory requirements and UCB global quality
standards
To represent Clinical Development Quality at interdepartmental and project team meetings
taking the leadership role when required, and dealing with complex and difficult or
important project issues
To deliver presentations to peers, senior management, and industry audiences, acting as a
role model for change
Helps develop, coach and mentor junior colleagues, generating enthusiasm and
encouraging new ideas.
JOB DESCRIPTION
Describe the minimum level of
education necessary for this role:
Bachelors
Experience
List the type and length of experience
10 plus years of background, knowledge and experience
of the (bio)Pharma industry and applicable technical
aspects of the business.
3 to 5 years previous experience on Clinical Quality
within a CRO or in Pharma
In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and
international), quality principles, inspection preparation and hosting, risk management and relevant
business processes and techniques.
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