Senior Issue Lead - FSP Job at Parexel

New

Technical Computing Architect (Senior or Lead)

At Boeing, we innovate and collaborate to make the world a better place. We’re c...

Location

United States , Herndon

Salary:

153000.00 - 249550.00 USD / Year

Boeing

Expiration Date

May 14, 2026

Requirements

Experience managing and maintaining cloud environments, servers, workstations, related infrastructure components, and software systems
In-depth knowledge and experience with networking, cloud, software, and various versions of Windows and Linux Servers
Experience with Active Directory, Group Policy, DNS, DHCP, and other core system/network services
Advanced troubleshooting skills and problem-solving abilities and able to diagnose and resolve complex technical issues
Strong knowledge of security best practices
Familiarity with on-premises virtualization technologies such as VMware, Hyper-V, ProxMox, and/or AHV
This position requires an active TS/SCI U.S. Security Clearance and current Full Scope Polygraph (FSP) (U.S. Citizenship Required)
Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, or related technical field
Level 4: 5+ years of related work experience or an equivalent combination of education and experience
8+ years of experience in Software, Solutions Architect, Cloud Engineering, and/or Systems Administration

Job Responsibility

Promote and lead implementation of the overall program's technical vision, in partnership with the Portfolio Chief Engineer
Promote the established Portfolio's engineering processes and best practices
Ensure consistent design and implementation across features
Be responsible for coordination and documentation of the epics, tasks, and sub-tasks documented in Jira
Help resolve the hardest technical issues and document the debugging steps and solutions
Be responsible for project design, implementation, testing, training and deployment
Support Project and Program Management, in partnership with the Portfolio Chief Engineer
Staying up to date with the latest technologies, industry trends, and security practices, and continuously improving skills and knowledge

What we offer

competitive base pay and variable compensation opportunities
health insurance
flexible spending accounts
health savings accounts
retirement savings plans
life and disability insurance programs
paid and unpaid time away from work
generous company match to your 401(k)
industry-leading tuition assistance program pays your institution directly
fertility, adoption, and surrogacy benefits

Fulltime

!

Senior Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP
Extensive clinical/scientific writing skills
Scientific background essential
writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar
Advanced word processing skills, including MS Office (expertise in Word)
software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel)
Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation
Excellent interpersonal, verbal, and written communication skills
Ability to consistently produce documents of high quality

Job Responsibility

Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy
Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable
Perform literature searches/reviews as necessary to obtain background information and training for development of documents
Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing
Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
Confirm data consistency and integrity across the document
Prepare documents for publishing readiness, when applicable
Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable
Provide suggested alternative content when contributors provide content that does not meet document needs

What we offer

Foster a culture of inclusivity, collaboration, and support
Continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team
Development and promotion based on global standards and your personal development plan
Supportive and inclusive environment
Career growth and development
Mentorship
Flexible work
Diverse projects
Culture of excellence
Global exposure

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Head of Japan Regulatory Strategy for Oncology and Rare Disease

Facilitate patient access to Amgen products in Japan through executing on our fi...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 11 years of directly related experience including 6+ years of experience in Regulatory Affairs
OR Master’s degree and 13 years of directly related experience including 8+ years of experience in Regulatory Affairs
OR Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience working with PMDA/MHLW, CROs, and/or contractors
Ability to lead teams
Strong communication skills - both oral and written in Japanese and in English (TOEIC score ≥860 desirable)
Ability to understand and communicate scientific/clinical information
Understanding of regulatory activities and how they affect projects and processes
Ability to set organizational direction & champion change and continuous improvement

Job Responsibility

Provides local input to developing and executing regulatory strategies and effective key regulatory agency interactions
Ensures local labels are developed and maintained in line with local legislation and Amgen standards and procedures
Supervisory oversight for multiple regulatory staff
Be a key point of contact for Japan Regulatory
Senior contact point for regulatory advice for commercial and medical projects for Japan
Translates global and international business plans to local regulatory
Represents Regulatory on Japan affiliate
Contributes to and execute filing plan for Japan
Develops local expertise to evaluate and achieve regulatory success based on proposed strategies
Supports the monitoring, auditing and self-assessment activities under the compliance framework

Fulltime

New

Senior Clinical Research Associate

Senior Clinical Research Associate, FSP Model, Paris, Hybrid or Home based, Prod...

Location

France , Paris

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or medicine
Extensive experience as a Clinical Research Associate (4/5 years independent monitoring or more), with a proven track record of managing complex trials within a CRO or Pharma environment
Fluency in French and professional proficiency in English (mandatory for reporting and international stakeholder management)
In-depth knowledge of ICH-GCP guidelines
Proven ability to manage multiple high-priority sites and projects simultaneously, with superior organizational and problem-solving skills
Excellent communication and interpersonal skills, with the ability to influence site compliance and represent a leading global sponsor effectively
Ability to travel as required to clinical sites and should possess a valid driver's license

Job Responsibility

Independently monitor Phase II–IV clinical trials as a senior resource dedicated to a major French pharmaceutical leader, ensuring full compliance with ICH-GCP and specific sponsor SOPs
Manage clinical studies in France across multiple complex therapeutic areas including Neurology, Rare Disease, Dermatology and Oncology
Lead site qualification, initiation, monitoring, and close-out visits, providing expert oversight and ensuring the highest standards of site performance
Ensure protocol compliance, data integrity, and participant safety through rigorous source data verification and proactive site management
Build and maintain influential relationships with investigators and site personnel to drive recruitment and facilitate smooth trial operations within this exclusive partnership
Perform advanced data review and resolution of complex queries to maintain the highest quality of clinical data within the sponsor’s proprietary systems
Contribute to the preparation, review, and optimization of study documentation, including monitoring plans and clinical study reports
Oversee study documentation, regulatory submissions, and ethics/IRB approvals to ensure strict adherence to trial timelines
Drive study cost efficiency and provide proactive resolution for site-level issues to meet critical milestones for our pharmaceutical partner

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

Datacenter Network SME

Implementation & Deployment: Lead the deployment, commissioning, and testing of ...

Location

United States , Alpharetta

Salary:

60.00 USD / Hour

Realign

Expiration Date

Until further notice

Requirements

Lead the deployment, commissioning, and testing of Ciena optical and packet networking equipment (6500, 5400, 8700 series) or ADVA FSP 3000, 150, or 3000C
Experience with Ciena 6500, Site Manager, and Metro Field Tech scenarios
Good knowledge in Routing and Switching Level 3 (With CCNP/CCIE Certificate)
Very good understanding on BGP and OSPF is a must
Perform complex, in-service upgrades and migrations without impacting end-user traffic
Configuring and managing network management systems (NMS)
Supporting optical transport network design (DWDM/CWDM)
Serve as an escalation point for field engineers and customers to resolve complex issues
Deep understanding of DWDM, OTN, SONET/SDH, and Ethernet
Experience with Optical Transport Networking (OTN) equipment

New

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Drexel Hill

Salary:

Not provided

CVS Health

Expiration Date

June 22, 2026

Requirements

Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
State-level licensure and national certification requirements vary by state, click here to learn more
Regular and predictable attendance, including nights and weekends
Ability to complete required training within designated timeframe
Attention and Focus
Customer Service and Team Orientation
Communication Skills
Mathematical Reasoning

Job Responsibility

Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
Contributing to positive patient experiences by showing empathy and genuine care
Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team
Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
Understanding and complying with all relevant federal, state, and local laws, regulations, professional standards, and ethical principles
Delivering additional patient health care services (e.g., immunizations, point-of-care testing, and voluntarily staffing offsite clinics), where allowable by law and supported by required training and certification
Where permissible, the Pharmacy Technician may also support immunizations, which includes the following responsibilities: Completing additional licensure and training requirements, in compliance with state Board of Pharmacy regulations, to obtain Technician Immunizer status to support preparing and administering vaccines
Educating patients about the importance of vaccines and referring patients to the Pharmacist-on-duty for vaccination questions

What we offer

medical, dental, and vision coverage
paid time off
retirement savings options
wellness programs
and other resources, based on eligibility

Fulltime

New

Mri Technologist

MedPro Healthcare Staffing, a Joint Commission-certified staffing agency, is see...

Location

United States , Springfield

Salary:

Not provided

MedPro Healthcare Staffing

Expiration Date

Until further notice

Requirements

Completion of a two year approved School of Radiologic Technology
Valid state radiology registration as required by state law
Registry by the American Registry of Radiologic Technology.

Job Responsibility

MRI technologists utilize their knowledge of anatomy, physiology and the principles of MRI to safely and efficiently operate MRI scanners, assisting in the diagnosis of disease and injury.
Ensure the safety of patients, staff and visitors who come in contact with the powerful magnetic field of a MRI scanner.
Position patients and coils on a table that slides inside the MRI scanner.
Inject contrast media as required.
Set appropriate technical parameters, operate MRI scanners and related equipment, and observe image data on computer monitors during scans.
Be familiar with the differences from a normal image and an abnormal image.
Recognize and respond to life threatening situations.
Assure compliance with federal, state, and local technical and professional regulations and accepted practiced guidelines.
Delivers quality, cost effective patient care in a professional manner.
Works effectively to maintain an environment of excellence, which is patient focused, providing timely, compassionate, quality patient care.

What we offer

Weekly pay and direct deposit
Full coverage of all credentialing fees
Private housing or housing allowance
Group Health insurance for you and your family
Company-paid life and disability insurance
Travel reimbursement
401(k) matching
Unlimited Referral Bonuses up to $1,000

Fulltime

Senior Issue Lead - FSP

Parexel

Location:
Brazil

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 18, 2026

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