Parexel

Medical writer

• Leads or contributes to the preparation and compilation of aggregate safety reports.
• Reviews and finalizes safety documents for accuracy and compliance.
• Coordinates submissions to regulatory authorities.
• Conducts literature searches and systematic reviews.
• Identifies complex data discrepancies.
• Supports development of Risk Management Plans.
• Actively contributes to safety strategy discussions.
• Serves as primary client liaison for projects.
• Monitors KPIs and SLAs for assigned deliverables.
• Mentors junior team members by providing training.

Medical Writer – Patient Safety

• Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions.
• Develops strategic approaches for challenging safety submissions.
• Reviews and approves high-complexity safety documents.
• Manages meeting logistics including scheduling, agenda drafting, and minute preparation.
• Designs and implements advanced signal detection plans tailored to specific product profiles.
• Leads signal detection for priority products by conducting expert-level analyses.
• Authors and reviews high-priority signal assessment reports and health authority response documents.
• Prepares and handles reviews of health authority response documents.
• Collaborates with cross-functional teams to ensure RMPs are scientifically robust and compliant.
• Demonstrates deep expertise in safety profiles across a wide range of therapeutic areas.

Senior Medical Writer, Patient Safety

• Independently lead the preparation/update of complex aggregate safety reports across multiple product types
• Manage the distribution of final reports to stakeholders, including partners and health authorities
• Leads advanced safety signal detection and management for key products
• Collaborates with cross-functional teams to analyze complex safety data
• Provides strategic scientific expertise across therapeutic areas

Principal Medical Writer, Patient Safety

Manager

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
• Develop and negotiate clinical site budgets based on Fair Market Value.
• Negotiate agreement language and budget with clinical study sites.
• Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
• For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources.
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
• Support internal and external audits activities.
• Ensure compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology and security.
• Ensure that all contracts are included in the TMF.

Senior Study Contract Manager - FSP

Research Analyst

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable laws, Good Clinical Practices
• Manage operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock
• Interface with the study team, facilitate information flow between team members and vendors
• Monitor site level AEs and SAEs, collaborate with Drug Safety Unit and follow-up with investigators

Senior Clinical Research Associate – Oncology

SDET

• Support quality control of functional or cross-functional systems in line with Parexel's strategies
• Manage selection/creation of relevant testing scenarios
• Conduct Software Quality reviews of functional requirements
• Write and execute functional & non-functional test plans/cases within an agile environment
• Test software to ensure compliance with SOPs, regulatory requirements
• Create test cases, traceability records, and regression test packs
• Analyze bugs and errors, document the results, and track defects
• Collaborate with stakeholders to report on progress and system quality

Software Quality and Test Engineer

• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs
• Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely
• Partner with Clinical Trial Liaison (CTL) and other client functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables
• Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct
• Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements
• Prepare and maintain Oversight Monitoring Plan
• Perform review of study metrics, assess CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits
• Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA
• Review site source documentation and verify accurate data capture (ALCOA principles)
• Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items
• Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting
• Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner
• Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents)
• Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary
• Track, trend, and report issues, escalating them to the appropriate teams when required
• Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs
• Actively participate in team meetings and process improvement initiatives to enhance study outcomes
• Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables

Full-stack Engineer

• Apply data analysis, data modeling, and quality assurance techniques based upon a detailed understanding of business processes.
• Develop and maintain specialist knowledge of database concepts, object and data modeling techniques and design principles.
• Design, code, test, correct and document complex programs and scripts from agreed specifications.
• Design and develop ETL mappings and workflows using Qlik or Informatica.
• Mentor and provide technical guidance for Software Engineers.
• Support technical consulting activities to clients in the pharmaceutical industry.
• Provide application support for existing products.

Senior Software Engineer

Project Manager

• Responsible for defining, developing and delivering the global study start up project strategy
• Manage and coordinate study start up activities globally
• Lead start up sub team for the study, region(s) or countries assigned
• Deliver site activations to plan for studies across high operational complexity
• Accountable for quality and completeness of start up timeline plans at study, country and site level

Start Up Project Manager II

Analyst

🌐
Worldwide
❌ Jobs You've Hidden
⭐️ Saved Jobs
✅ Applied Jobs
✉️ Email Alerts
👤 Account
This job opening is no longer available.
Similar Jobs
IT Service Desk Analyst

🕒 5 days ago

Resolv Global

51 - 200

🤝 B2B

🎯 Recruiter

Website
LinkedIn
All Job Openings

Service Desk Analyst at Resolv.Global Support providing first-level technical support and troubleshooting for end users. Resolving hardware, software, and access-related issues in a performance-driven remote environment.

🇿🇦 South Africa – Remote

💵 $6 / hour

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 Analyst

🚫👨‍🎓 No degree required

IT Service Desk Analyst

🕒 5 days ago

Resolv Global

51 - 200

🤝 B2B

🎯 Recruiter

Website
LinkedIn
All Job Openings

IT Service Desk Analyst providing first-level technical support and troubleshooting for end users in a fast-paced environment. Must be flexible to support users across varying schedules.

🇿🇦 South Africa – Remote

💵 $6 / hour

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 Analyst

🚫👨‍🎓 No degree required

IT Service Desk Analyst

🕒 5 days ago

Resolv Global

51 - 200

🤝 B2B

🎯 Recruiter

Website
LinkedIn
All Job Openings

Customer-focused Service Desk Analyst providing first-level technical support in a remote work environment. Troubleshooting and resolving IT issues while maintaining high-quality service standards.

🇿🇦 South Africa – Remote

💵 $6 / hour

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 Analyst

🚫👨‍🎓 No degree required

IT Service Desk Analyst

🕒 5 days ago

Resolv Global

51 - 200

🤝 B2B

🎯 Recruiter

Website
LinkedIn
All Job Openings

Service Desk Analyst providing first-level technical support remotely for end users. Join Resolv.Global to troubleshoot technical issues and ensure high-quality customer service.

🇿🇦 South Africa – Remote

💵 $6 / hour

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 Analyst

🚫👨‍🎓 No degree required

IT Service Desk Analyst

🕒 5 days ago

Resolv Global

51 - 200

🤝 B2B

🎯 Recruiter

Website
LinkedIn
All Job Openings

IT Service Desk Analyst providing first-level technical support for end users at Resolv.Global. Ideal for candidates with IT support experience and strong troubleshooting skills in a remote environment.

🇿🇦 South Africa – Remote

💵 $6 / hour

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧐 Analyst

🚫👨‍🎓 No degree required

Search More Analyst Jobs
🌐
Worldwide
Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com
Search
Search Jobs by country
Search jobs by city
Search jobs by job title
Search entry-level jobs
Search junior-level jobs
Search senior-level jobs
Search jobs by tech stack
Search jobs by contract type
Search remote internships
Search remote part-time jobs
Remote jobs Anywhere in the World
Companies Hiring Anywhere in the World
Companies Hiring Sales People Anywhere in the World
Companies Hiring Software Engineers Anywhere in the World
Resources
Advice
Tips for finding remote jobs
Interview questions and answers
Resume examples
Cover letter examples
Post a job
Affiliates
Privacy policy
Terms of service
Job board SEO course
AI Apply Copilot
OpenClaw job finder
Jobs by Country
Remote jobs anywhere in the world (Worldwide remote jobs)
Remote jobs United States
Remote jobs Australia
Remote jobs Brazil
Remote jobs Canada
Remote jobs France
Remote jobs Ireland
Remote jobs Germany
Remote jobs Netherlands
Remote jobs Spain
Remote jobs UK
Popular Jobs
Remote data analyst jobs
Remote customer support jobs
Remote executive assistant jobs
Remote marketing jobs
Remote product designer jobs
Remote product manager jobs
Remote project manager jobs
Remote recruiter jobs
Remote sales jobs
Remote software engineer jobs
Jobs by Type
Remote full-time jobs
Remote part-time jobs
Remote contract jobs
Remote internship jobs
Remote entry-level jobs
Remote jobs with no experience required
Remote junior jobs (1-3 years of experience)
Digital nomad jobs
Remote jobs with no degree required
Freelance remote jobs
Temporary remote jobs
Remote jobs hiring now
Stay at home mom jobs

Data Surveillance Analyst

Vice President

• Create a working environment that demands discipline across all aspects of project delivery
• Establish a team of leaders with emotional intelligence, and a desire for authentic working relationships
• Engage with Department Senior Leadership as a strategic advisor
• Measure success through delivery of clinical services across the portfolio of studies managed by Directors and Project Leaders in finance, utilization, quality, compliance, and delivery
• Maintain targets for profitability, margin expansion, cash flow, and contractual coverage across all projects within the portfolio
• Interrogate financial data related to operational delivery
• Drive teams to comply with data entry and accuracy
• Participate in Risk Governance and routine surveillance of the portfolio to identify risk trends
• Promote a holistic view of project quality and assess impact on patients, customers, investigators, and key stakeholders
• Manage Employee Performance aligned to Parexel’s Talent Philosophy
• Participate in a robust resource strategy
• Ensure compliance with training needs and opportunities

Vice President, Project Leadership

• Works closely with Precision Medicine Leadership and cross-functional study teams to ensure quality samples and data are proficiently managed
• Participate in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
• Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing
• Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
• Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens

Clinical Laboratory Study Manager

Compliance

• Understand the regulatory framework and regional trends for various types of applications
• Support Annual reports/Renewals in multiple regions
• Liaise with cross-functional members with aligned product responsibilities
• Evaluate changes according to country guidelines
• Manage lifecycle activities in the EU markets

Regulatory Affairs Associate – Annual Report / Renewals, Biologics

• Lead Parexel and Sponsor teams by leveraging clinical research experience and project management skills
• Ensure operational excellence and successful execution of clinical operations and strategies for EP clinical trials or programs
• Manage the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices
• Own the sponsor relationship and manage sponsor communication
• Proactively communicate project progress, risks, and solutions to sponsors and internal teams
• Manage study start-up activities and ensure best practices are implemented
• Lead projects to completion within budget and schedule, ensuring contract specifications are met
• Identify potential project risks and implement contingency plans

Project Manager – Early Phase

• Drive study performance at the sites
• Perform site monitoring and other onsite visit activities
• Provide the required monitoring visit reports within required timelines
• Proactively identify study-related issues and escalates to Local Study Teams
• Train, support and advise Investigators and site staff in study related matters

Medical Writer – Patient Safety

Senior Medical Writer, Patient Safety

Principal Medical Writer, Patient Safety

Senior Study Contract Manager - FSP

Senior Clinical Research Associate – Oncology

Software Quality and Test Engineer

Senior Clinical Research Associate – Oncology

Senior Software Engineer

Start Up Project Manager II

Data Surveillance Analyst

Vice President, Project Leadership

Clinical Laboratory Study Manager

Regulatory Affairs Associate – Annual Report / Renewals, Biologics

Project Manager – Early Phase

Clinical Research Associate II – FSP