CrawlJobs Logo

Senior Issue Lead - FSP

parexel.com Logo

Parexel

Location Icon

Location:
Brazil

Category Icon
Category:
Quality Control

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

The Senior Issue Lead will ensure that each confirmed case is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done on the case to enable a meaningful investigation with appropriate quality outcomes which includes a case summary which meets defined quality standards and can be used for a regulatory inspection. The Senior Issue Lead will perform quality review and approval of select quality events which have been managed by other investigation leads. He/she will be assigned to process improvement initiatives and special projects as necessary and be expected to drive changes to the business process for case management when the need arises.

Job Responsibility:

  • Quality Event Investigation
  • Training and Technology
  • Audit and Inspection Coordination
  • Quality Compliance Assessment
  • Root Cause Analysis

Requirements:

  • BS – 10+ years or equivalent
  • MS/MBA – 9+ years or equivalent
  • Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
  • Regulatory inspection experience
  • Process and system management experience
  • Detailed knowledge of clinical trial processes and relationships required
  • Knowledge of GCP requirements and applicable SOPs and regulations
  • Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
  • Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

Additional Information:

Job Posted:
January 18, 2026

Work Type:
Remote work
Icon
Parexel - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon
PREMIUM
More languages and countries
Unlock 29494 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Issue Lead - FSP

Senior Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...
Location
Location
United States
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...
Location
Location
Turkey
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
What we offer
  • Flexible work arrangements
  • Career growth and development
  • Supportive and inclusive environment
  • Diverse therapeutic areas and project exposure
  • Advanced Technology
Read More
Arrow Right

Head of Japan Regulatory Strategy for Oncology and Rare Disease

Facilitate patient access to Amgen products in Japan through executing on our fi...
Location
Location
Japan , Tokyo
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Datacenter Network SME

Implementation & Deployment: Lead the deployment, commissioning, and testing of ...
Location
Location
United States , Alpharetta
Salary
Salary:
60.00 USD / Hour
realign-llc.com Logo
Realign
Expiration Date
Until further notice
Flip Icon
Requirements
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
Read More
Arrow Right
New

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...
Location
Location
Canada
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Demonstrated clinical research experience
  • Demonstrated start up experience
  • Demonstrated project management experience
  • Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
  • Concurrent management of complex processes within and across countries in multiple regions of the world
  • Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
  • Expert ability to comprehend status and adapt communications across a diverse audience
  • Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
  • Will use generative artificial intelligence techniques in daily work
  • Uses risk management techniques as standard to identify and mitigate key project delivery risks
Job Responsibility
Job Responsibility
  • Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
  • Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
  • The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
  • As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
  • Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
  • Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
  • The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
  • Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
  • Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
  • In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies
Read More
Arrow Right
New

Senior Salesforce Administrator

Carex is partnering with a healthtech startup partner to hire a Senior Salesforc...
Location
Location
United States , Chicago
Salary
Salary:
55.00 - 65.00 USD / Hour
carexconsulting.com Logo
Carex Consulting Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of Salesforce Administration experience or similar CRM platform experience
  • Advanced Salesforce Administrator certification required
  • Deep understanding of Salesforce Flow Builder and platform automations
  • Strong analytical and problem-solving skills with the ability to communicate effectively across technical and non-technical audiences
  • Proven ability to navigate ambiguity and deliver impactful solutions in a rapidly changing environment
  • Excellent organizational and time management skills with the ability to balance competing priorities
  • Experience supporting sales operations, data management, and Salesforce administrative functions
  • Interest in continuing to expand Salesforce and business systems expertise
Job Responsibility
Job Responsibility
  • Lead the execution of Salesforce project deliverables across multiple business channels
  • Participate in all phases of the Salesforce development lifecycle including discovery, analysis, requirements gathering, solution design, configuration, testing, deployment, release management, change management, and ongoing support
  • Design scalable Salesforce solutions with a focus on flexibility, maintainability, and long-term platform health
  • Support system health and data integrity by proactively identifying issues and driving resolution
  • Build and maintain reports, dashboards, controls, and documentation to support operational effectiveness
  • Manage a mix of tactical support requests and larger strategic initiatives simultaneously
  • Collaborate with internal stakeholders including leadership, sales, IT, vendors, and cross-functional teams
  • Assist in mentoring and supporting other Salesforce administrators as needed
  • Fulltime
Read More
Arrow Right
New

Part-Time Store Cashier/Stocker

ALDI is looking for enthusiastic part-time cashiers and stockers. As a cashier, ...
Location
Location
United States , East Pensacola Heights
Salary
Salary:
17.50 - 19.50 USD / Hour
stores.aldi.us Logo
Aldi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 18 years old required
  • High school diploma or equivalent preferred
  • Prior work experience in a retail environment preferred
  • Ability to provide prompt and courteous customer service
  • Ability to operate all store equipment such as cash registers, floor scrubber, cardboard baler, pallet jacks, handheld devices, computers, etc.
  • Ability to interpret and apply ALDI operating policies and procedures
  • Ability to effectively communicate both verbally and in writing
  • Ability to perform basic arithmetic such as addition, subtraction, multiplication, and division
  • Ability to follow instructions and pay attention to detail
  • Ability to work both independently and with others
Job Responsibility
Job Responsibility
  • Provide friendly, efficient checkout service
  • Help keep shelves stocked and organized
  • Model and fulfill all customer service principles and escalate concerns to store management as necessary
  • Assist store management in achieving operational efficiency goals
  • Assist store management in achieving total loss goals
  • Comply with all established company policies and processes
  • Support store management in providing a safe working environment by identifying and rectifying hazards, ensuring proper ergonomics, and maintaining equipment in proper working order
  • Maintain store zones standards and merchandising standards at all times
  • Adhere to inventory procedures and product handling guidelines
  • Perform general cleaning tasks to company standards
What we offer
What we offer
  • 401(k) Plan
  • Company 401(k) Matching Contributions
  • Employee Assistance Program (EAP)
  • PerkSpot National Discount Program
  • Parttime
Read More
Arrow Right
New

Part-Time Store Cashier/Stocker

ALDI is looking for enthusiastic part-time cashiers and stockers. As a cashier, ...
Location
Location
United States , Richfield
Salary
Salary:
19.00 - 21.00 USD / Hour
stores.aldi.us Logo
Aldi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ability to provide prompt and courteous customer service
  • Ability to operate all store equipment such as cash registers, floor scrubber, cardboard baler, pallet jacks, handheld devices, computers, etc.
  • Ability to interpret and apply ALDI operating policies and procedures
  • Ability to effectively communicate both verbally and in writing
  • Ability to perform basic arithmetic such as addition, subtraction, multiplication, and division
  • Ability to follow instructions and pay attention to detail
  • Ability to work both independently and with others
  • Ability to organize, prioritize and complete assigned tasks to maximize productivity within established timeframes
  • Ability to maintain reliable and prompt attendance
  • Ability to meet availability requirements
Job Responsibility
Job Responsibility
  • Models and fulfills all customer service principles and escalates concerns to store management as necessary
  • Assists store management in achieving operational efficiency goals
  • Assists store management in achieving total loss goals
  • Complies with all established company policies and processes
  • Supports store management in providing a safe working environment by identifying and rectifying hazards, ensuring proper ergonomics, and maintaining equipment in proper working order
  • Maintains store zones standards and merchandising standards at all times
  • Adheres to inventory procedures and product handling guidelines
  • Performs general cleaning tasks to company standards
  • Properly utilizes the point-of-sale (POS) system to accurately scan and process customer purchases and informs store management of scanning concerns or errors
  • Adheres to cash policies and procedures
What we offer
What we offer
  • 401(k) Plan
  • Company 401(k) Matching Contributions
  • Employee Assistance Program (EAP)
  • PerkSpot National Discount Program
  • Parttime
Read More
Arrow Right