Senior Issue Lead - FSP Job at Parexel

New

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

New

Produce Clerk

Produce Clerk is responsible for smiling and greeting all customers while delive...

Location

United States , North Hollywood

Salary:

18.77 - 22.55 USD / Hour

Vallarta Supermarkets

Expiration Date

Until further notice

Requirements

Must enjoy working with the public
Must have good communication skills
Must have a friendly, courteous attitude, and provide extraordinary customer service
Must exhibit a responsible, professional, and positive attitude towards the job, co-workers, and customers
Must have a positive attitude, towards safety, and be committed to follow all health and safety regulations and/or polices to ensure the well-being of oneself, fellow team members, customers and vendors
Must be able to work a flexible schedule including weekends and holidays
Must be able to transfer to other locations within a reasonable commute of home store
Must be able to work in refrigerated coolers and around humidity for short periods of time
Ability to meet the physical requirements of the job
No experience necessary, must have a friendly, courteous attitude, and provide extraordinary customer service

Job Responsibility

Smiling and greeting all customers while delivering extraordinary customer service
Responds to customers’ requests in locating products
Maintains produce wet rack, displays, and shelves well stocked, clean, organized, and presentable at all times
Responsible for trimming, rotating, and replenishing products to ensure product freshness and quality

Parttime

New

Airport Ramp Agent

The Ramp Agent is responsible for loading and offloading our guests’ baggage, en...

Location

United States , Honolulu

Salary:

16.00 USD / Hour

Alaska Air Group

Expiration Date

January 23, 2026

Requirements

Must be willing and able to work outside in the elements
Ability to lift 70lbs. throughout your shift
Must be able to bend, stoop, squat, reach and grasp
Must be willing and able to work in confined spaces on your knees/elbows, lifting baggage overhead frequently (weighing 70+ lbs.), operating heavy machinery near the aircraft, drive tugs, and more
Must have a valid unexpired driver’s license issued by a US state, a US territory or the District of Columbia
Flexible to work varied shifts including nights, weekends, and holidays
Ability to obtain USPS Mail Handling Certification
Ability to obtain airport security clearance
Ability to communicate in English
High school diploma or equivalent

Job Responsibility

Loading, stowing and unloading of all cargo and baggage in accordance with flight loading plans
Pick-up and delivery of all cargo, including mail, express, baggage, freight Company material, commissary supplies
Preparation, reporting and accounting of necessary documents relating to work performed
Cleaning of aircraft baggage pits and immediate work areas
Operation of automotive equipment in connection with the above duties, and only after proper training
Insert and remove chocks and safety lines
When mechanical personnel are not immediately available for the assignment, may receive and dispatch aircraft
May also be required to perform the duties of Cleaners: limited to cleaning of offices in surrounding areas and aircraft

What we offer

Free stand-by travel privileges on Alaska Airlines, Hawaiian Airlines & Horizon Air
Comprehensive well-being programs including medical, dental and vision benefits
Generous 401k match program
Quarterly and annual bonus plans
Generous holiday and paid time off

Fulltime

!

New

Process Development Manager

This is an excellent opportunity for an experienced Process Technologist or Seni...

Location

United Kingdom

Salary:

40000.00 - 45000.00 GBP / Year

Zest Food Jobs

Expiration Date

Until further notice

Requirements

food-related degree (or equivalent experience)
strong process development and validation experience within chilled or short shelf-life manufacturing
solid HACCP knowledge

Job Responsibility

lead all site process development activities
manage projects from handover through to factory launch
ensure new and reformulated products meet food safety, legal and quality standards
work closely with QA, Operations, NPD and Purchasing
responsibilities include validations
managing process and material changes
HACCP compliance
deputising for the Technical Manager when required
lead, coach and develop the Process Development team

What we offer

Package

New

Shift lead

That’s the great thing about a career at Walgreens. You get to bring health and ...

Location

United States , Columbia

Salary:

17.00 - 20.00 USD / Hour

Walgreens

Expiration Date

Until further notice

Requirements

One year of prior leadership, supervisory, or retail key holder work experience
Must be fluent in reading, writing, and speaking English. (Except in Puerto Rico)

Job Responsibility

Opens and closes the store in the absence of store management, including all required systems start-ups, required cash handling, and ensuring the floor and stock room are ready for the business day
Completes product returns, order voids, customer refunds, cash drops to the safe, and provides change as requested to cash registers
Models and delivers a distinctive and delightful customer experience
Engages customers and patients by greeting them and offering assistance with products and services
Models and shares customer service best practices with all team members
Responsible for holding store keys to open and close without management as necessary
Assists with and coaches other team members to work with warehouse and vendor ordering process
Responsible and accountable for registering all related sales on assigned cash register
Assists manager or assistant store manager in reviewing order exceptions on order release day and assists in reverse logistics
Assists manager or assistant store manager in evaluating and developing displays

What we offer

Health, dental and vision*
Paid time off benefits
Employee discount
Retirement Savings Plan (401(k))
Flexible hours
Training programs

New

Customer Advisor

We believe anyone can improve their home to make life better. Every day, we give...

Location

United Kingdom , Douglas

Salary:

14.85 GBP / Hour

B&Q

Expiration Date

Until further notice

Requirements

Valid documentation of entitlement to work on the Isle of Man, as issued by the Government of the Isle of Man

Job Responsibility

Provide ideas, advice, tools and confidence to customers to create a home they’ll love
Be a friendly face of the business
Provide advice and assistance to customers

What we offer

20% discount on purchases at B&Q after 3 months
Share schemes
Life assurance
Employee assistance programme
Pension
6.6 weeks' leave
Additional leave and cash rewards for long service
Flexible working
Shopping discounts
Gym discounts

New

Experienced Systems Engineer - Vehicle Management Systems

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

Location

India , Bengaluru, Bangalore

Salary:

Not provided

Boeing

Expiration Date

January 24, 2026

Requirements

Bachelor's degree or higher (BASIC QUALIFICATION)
Engineering degree (Electronics & Communication, Electronics & Telecommunication / Electrical & electronics) and 8 to 12 years related work experience, a master’s degree with 7+ years related work experience or an equivalent combination of education and experience
Demonstrate excellence in development of high-integrity systems such as Flight Controls Systems, Flight Management System (Guidance, Navigation, Flight Planning)
System Test / Verification experience, specifically with a focus on Navigation State Estimation
An understanding of the following sensors: INS, GNSS, Radar Altimeters, Air Data Systems
Demonstrate excellence in System design, integration & testing
Demonstrate excellence in development Assurance (ARP4754A)
Develop System test procedures
Perform Requirements Management in tools such as DOORS or equivalent
Having System Test automation experience, specifically utilizing Python

Job Responsibility

System development of Vehicle Management System (ARP4754A)
Design, system level requirements development, decomposing requirements, Validation & Verification and traceability of requirements, and supports FAA certification
Evaluates customer / operational needs to define and coordinate system performance requirements, functional requirements and regulatory requirements
Applies an interdisciplinary, collaborative approach to plan, design, develop and verify a lifecycle balanced system of systems and system solutions
Coordinates with engineering functions to define requirements related to safety, reliability, maintainability, testability, human systems integration, survivability, vulnerability, susceptibility, system security, regulatory, certification, product assurance and other specialty engineering groups
Develops the planning, organization, implementation and monitoring of requirements management processes, tools, risk, issues, opportunity management and technology readiness assessment processes
Resolves cross-functional technical issues
Present requirement, design and/or development revision and changes to formal change boards
Tests and validates to ensure system designs meet operational and functional requirements

What we offer

Competitive base pay and incentive programs
Industry-leading tuition assistance program pays your institution directly
Resources and opportunities to grow your career
Up to $10,000 match when you support your favorite nonprofit organizations
Relocation within INDIA based on candidate eligibility
Variable arrangements depending upon business and customer needs, and professional pursuits that offer greater flexibility in the way our people work

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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Senior Issue Lead - FSP

Parexel

Location:Brazil

Category:Quality Control

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Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

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