Senior Issue Lead - FSP Job at Parexel

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 / Principal Medical Writer - FSP

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

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
Excellent interpersonal, negotiation, verbal, and written communication skills
A flexible attitude with respect to work assignments and new learning
Motivation to work consistently in a fast-paced, rapidly changing environment
Ability to manage multiple / varied tasks with enthusiasm and prioritize workload with attention to detail
Competent working in a matrix environment and values the importance of teamwork
Possesses team leadership skills and cross-cultural sensitivity
Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate
Presents solutions and follows through to ensure problems have been satisfactorily resolved
Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned

Job Responsibility

Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training
Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
Manage ongoing and/or revised project documentation and correspondence
Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission
Project Management: Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents
Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project
Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences
Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence
Client Liaison/Service: Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management

What we offer

Structured career pathway and encouragement to develop within the role including awareness and understanding of the industry
Competitive base salary
Holiday
Private healthcare
Other benefits that you would expect with a top company in the CRO Industry

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

Apprentice Multitrader

Becoming an apprentice at AxisCLC is an excellent opportunity to gain practical ...

Location

United Kingdom , Liverpool

Salary:

8.00 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

GCSE 4 & above (A-C) in Maths & English or equivalent
Good communication
Presentable
Positive attitude to work
Attention to detail

Job Responsibility

Ensure the effective delivery of service in line with Axis Health and Safety policies and procedures
Ensure and undertake any recording of work and administration required by Axis standards and timescales
Report any Health and Safety issues and outstanding defects to your Supervisor, Contracts Manager, Health and Safety team and Apprentice Co-ordinator
Work as an integral team member with other apprentices, Axis operatives, clients, customers, and tenants
Attend Axis Induction, Health and Safety training, Toolbox talks and College Induction
Undertake multi-trade work to a safe, clean, and high-quality standard
Learn how to cost multi-trade area work with your Axis Mentor, identifying cost reduction methods
Ensure college course attendance is 100% and college absence communicated to your Line Manager and Apprentice Co-ordinator every time you fail to attend college
Ensure that you meet your operative on time daily
Communicate any absence from work as per your contractual terms and conditions

What we offer

Pension scheme and life assurance
Travel Expense Coverage: Enabling all apprentices to travel to/from college and/or apprentice/work-related events
23 days’ holiday + bank holidays
Access to Perkbox (discounts, perks & wellbeing offers)
1 paid volunteer day
Access to Learning and development opportunities: These include financial wellbeing, technical skills and coaching

Fulltime

New

Catering Assistant

Are you looking for that next step in your career, then you've come to the right...

Location

United Kingdom , Shafton

Salary:

7692.30 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Great customer service skills
ideally from a catering or retail background
ability to undergo an enhanced DBS check

Job Responsibility

Working as part of the catering team to provide a friendly, efficient and hygienic service
Assist in the preparation of food and snacks
Counter service and till work
Keeping the kitchen and restaurant areas in a clean and tidy state at all times

What we offer

Free meal supplied on shift
Free qualifications and career development opportunities
Staff discount scheme at over 850 retailers
Monthly opportunities for the best teams to win shopping vouchers
All school holidays off

Parttime

New

Domestic/laundry assistant

An exciting opportunity has arisen for a Domestic/Laundry Assistant to join our ...

Location

United Kingdom , Southport

Salary:

12.60 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Caring nature and positive attitude
desire to deliver high standard domestic and laundry service
previous domestic experience preferred
commitment to highest levels of cleanliness, hygiene and appearance
ability to demonstrate compassion and empathy towards older people
team player but able to work on own initiative
dependable and flexible to meet needs of residents and home
alternate weekend availability required

Job Responsibility

Ensuring clean safe environment for residents, visitors and staff
following daily schedule for cleaning
hoovering
dusting
polishing
shampooing carpets
mopping floors
any other duties as required
laundry duties for all clothing and bedding
ensuring everything is labelled and washed according to washing instructions

What we offer

Fortnightly pay
28 days paid annual leave (pro rata)
free uniform
cost of DBS paid
fully paid induction training
£200 refer a friend bonus

Fulltime

New

Senior Accounting Manager

My client, a Professional Services Firm in Boston is hiring a Senior Accounting ...

Location

United States , Boston

Salary:

130000.00 - 150000.00 USD / Year

Robert Half

Expiration Date

Until further notice

Requirements

Degree in Accounting, Finance or related
8+ years of Accounting experience
Professional Services Industry experience highly preferred

Job Responsibility

Report to the Director of Finance and oversee Accounting for the company

What we offer

Bonus
great benefits
growth potential
hybrid working arrangement

Fulltime

New

Senior Mobile Developer (React Native)

The Senior Mobile Developer (React Native) will play a crucial role in our engin...

Location

Romania , Cluj

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Bachelor’s degree in software engineering-related discipline (preferably in Computer Science)
A minimum of 5-7 years demonstrable experience in Mobile Development
Strong understanding of TypeScript both functional and objected oriented style
3+ years previous experience in working with React Native and NextJS
Building REST based microservices and an understanding of configuring/deploying services to cloud environments
Strong understanding of mobile application architecture best practices (e.g. MVP, MVVM, Flux)
Strong understanding of clean code and clean architecture concepts (e.g. SOLID, Onion)
Strong understanding of at least one layered backend application architecture (e.g. three tier, hexagonal, onion)
Excellent knowledge of test-driven development and testing pyramid
Comfortable pair programming with other developers when needed

Job Responsibility

Building clean, maintainable features and resolving end-to-end issues with an understanding of different possible approaches
Ensuring that the solutions developed and deployed are fit for purpose, provide appropriate business value, adhere to quality standards and align to standard engineering practices
Understanding and contributing to the strategy for the management of technical debt within the team
Analysing and defining test approaches and strategies within your team so that the customer experience is of the highest quality – with an emphasis security, usability and accessibility
Conducting and participating in code reviews with an emphasis on both functional and non-functional requirements, considering, performance, resiliency, maintainability and security
Enthusiastically promoting inspection and adaptation to improve team effectiveness & happiness, supporting changes to enhance processes and culture
Building a culture of mutual respect, collaboration and engagement within the team, coaching, mentoring and supporting less experienced engineers to develop and grow their skills
Undertaking continuous research on relevant application technologies and identify and implement opportunities to incorporate those into the application as appropriate

What we offer

Smooth integration and a supportive mentor
Pick your working style: choose from Remote, Hybrid or Office work opportunities
Projects have different working hours to suit your needs
Sponsored certifications, trainings and top e-learning platforms
Private Health Insurance
Individual coaching sessions or accredited Coaching School
Epic parties or themed events

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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