Senior writer Work, Jobs in Maidenhead, Brk (with Salaries)

Senior/ Medical Writer - FSP
IQVIA —Reading
- Full-time
- Hybrid work
- Microsoft Word
- Doctoral degree
- Master's degree
8d
Medical Writer
MedComms Experts —London
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Doctoral degree
Quick apply
Senior Communications Manager
Wickes —Watford
- Full-time
- Organisational skills
- Employee assistance programme
- Employee discount
Senior Account Manager/Account Director, Brand & Reputation
MHP Group —London
- Hybrid work
- Leadership
- Employee assistance programme
- Employee discount
Narrative Lead
Electronic Arts —Guildford
- Hybrid work
- Team management
- Mentoring
- Leadership
- Annual leave
Principal Biostatistician
Ergomed —Guildford
- Full-time
- Remote
- English
- Master's degree
- Presentation skills
Quick apply
Bid Writer
The Electric Car Scheme —Hayes
- £40,000 - £50,000 a year
- Hybrid work
- AI
Quick apply
Sales Lead
Scrumconnect Consulting —Staines-upon-Thames
- £65,000 - £70,000 a year
- Sales
- Agile
- Marketing
Account Director - Health
Edelman —London
- Full-time
- Business development
- Presentation skills
- Team management
Senior UX Designer
AKQA —London
- Communication skills
Senior Building Surveyor
Knight Frank —London
- Full-time
- AutoCAD
- Business development
- Mentoring
Senior Chef de Rang
The Arts Club - Brasserie —London
- Full-time
- Hospitality
- English
- Organisational skills
- Employee assistance programme
- Employee discount
Quick apply
7d
Chef De Partie / Senior Chef de Partie
The Arts Club - Main Kitchen —London
- £39,316 - £41,316 a year
- Full-time
- Hospitality
- Cooking
- English
- Employee assistance programme
- Employee discount
Quick apply
Senior Bartender
The Arts Club - TAC - Bar —London
- Full-time
- Serving
- Bar
- Management
- Employee assistance programme
- Employee discount
Quick apply
2d
Deputy General Manager - Maternity cover
The Arts Club - Brasserie —London
- Full-time
- Sales
- Team management
- Recruiting
- Employee assistance programme
- Employee discount
Quick apply
11d
Lead Cloud Automation Developer – Sofia, BG
Xtravirt —Leatherhead
- Hybrid work
- English
- Communication skills
- Referral programme
Commis Chef
The Arts Club - Ofelia - Kitchen —London
- Full-time
- Hotel
- Organisational skills
- Hotel experience
- Employee assistance programme
- Employee discount
Quick apply
2d
Senior Medical Writer- London
Emotive —London
- £48,000 - £55,000 a year
- Full-time
- Hybrid work
- Doctoral degree
- Microsoft Office
- Communication skills
- Annual leave
- Gym membership
Quick apply
Senior Manager, Digital Content Strategy
Cytiva —Amersham
- Full-time
- Marketing
- Analysis skills
- Bachelor's degree
- Annual leave
2d
Commis Waiter
The Arts Club - Kyubi —London
- Full-time
- Cleaning
- Guest services
- Restaurant
- Employee assistance programme
- Employee discount
Quick apply

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Senior/ Medical Writer - FSP

IQVIA -
Reading

Apply Now

Job details

Full-time
8 days ago

Qualifications

Content quality assurance review
Microsoft Word
Document control
Meeting coordination
Clinical research
Doctoral degree
Stakeholder collaboration
Master's degree
Bachelor's degree
Quality control
Project schedule tracking
Document control software
Multidisciplinary collaboration
Editorial workflow management
Document management
Cross-functional collaboration
Document management systems
Communication skills
Healthcare writing experience
Cross-functional communication
Project progress tracking
Time management
Analytics

Full job description

Reading, United Kingdom | Full time | Hybrid | R1560755

The FTE Medical Writer will serve as an integrated member of the team, delivering medical writing services for the development of clinical documents, including Clinical Trial Reports (CTRs), Trial Design Outlines/Clinical Trial Protocols (TDOs/CTPs) and CTP amendments, Briefing Books, Investigator’s Brochures (IBs) and IB updates, Biomarker Reports, and submission documents such as the Summary of Clinical Efficacy and Safety, etc. Emphasis will be placed on the therapeutic areas of eye health and inflammation; senior-level experience in these areas is preferred.

The FTE Medical Writer will work on a dedicated basis and be embedded in sponsor’s processes and workflows, including Feedback and Alignment Meetings. In this role, the FTE Medical Writer will participate in ongoing project-related activities, such as planning, project discussions, and all required training sessions. The FTE Medical Writer will adopt sponsor’s systems, tools, and methodologies to ensure seamless collaboration and alignment with internal teams.

Tasks typically include, but are not limited to:

Document management: Set-up and management of clinical document in the Electronic Document Management System (EDMS)
Review and approval of the Statistical Analysis Plan in the EDMS
Management of timelines including proposal of timelines to trial/project team (based on timelines communicated by sponsor), finalising them after agreement, and updating them as appropriate
Preparation for and attendance of the required trial team meetings or submission meetings
Preparation, conduct, and documentation of kick-off meetings, e.g. for TDO/CTP, IB or CTR writing
Preparation, conduct, and documentation of Results Alignment Meetings (RAM; not applicable for Phase I in healthy volunteer studies)
Writing of drafts including appropriate in-text tables and figures according to the timelines agreed upon with trial/project team
Provision of drafts and management of all review cycles by the trial/project team, reaching consensus on comments/changes, integration of changes into the text, and completion of the Review Documentation Form (as applicable)
Initiation and monitoring or conducting of Quality Control (QC) checks as well as completion of the Quality Control Documentation Form (QCDF)
Creation and provision of the final document version to the trial/project team
Initiation of publishing and pre-archive checks, monitoring and resolution of findings
E-approval of final clinical document in the EDMS
Technical checks after the final draft of initial IBs and IB updates in the EDMS, and by going through a Final Formatting checklist document
FTE Medical Writer will follow the appropriate process as per document type and according to sponsor SOPs

Qualifications

Bachelor’s degree in a scientific, clinical, regulatory, or related field required; advanced degree (e.g., MSc, PhD, PharmD, MD) preferred
Approx 5 years of experience in medical writing within the biopharmaceutical, biotechnology, or CRO industry; equivalent experience in clinical or preclinical development will also be considered
Strong knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA) across all phases of clinical development
Broad understanding of clinical research processes, including study design, data analysis, and regulatory submission requirements
Demonstrated ability to lead writing activities for complex documents and provide strategic input to cross-functional teams
Excellent written and verbal communication skills, with the ability to clearly and accurately present complex scientific and clinical information
Strong organizational, time management, and project management skills, with the ability to manage multiple priorities and meet tight deadlines
Proven ability to work collaboratively in a cross-functional, team-oriented environment while also operating independently when needed
High attention to detail with a commitment to quality, consistency, and scientific accuracy
Proficiency in Microsoft Word and document formatting best practices
Experience with electronic document management systems (eDMS) and familiarity with document templates, style guides, and structured authoring tools

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Where you'll work

Hybrid

You’ll split your time between home and the office, giving you the flexibility to focus where you work best while still building strong in-person connections with your team. This model combines the autonomy of remote work with the collaboration, energy and resources of an office environment.

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

Apply Now

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senior writer jobs in maidenhead, brk

Senior/ Medical Writer - FSP

Medical Writer

Senior Communications Manager

Senior Account Manager/Account Director, Brand & Reputation

Narrative Lead

Principal Biostatistician

Bid Writer

Sales Lead

Account Director - Health

Senior UX Designer

Senior Building Surveyor

Senior Chef de Rang

Chef De Partie / Senior Chef de Partie

Senior Bartender

Deputy General Manager - Maternity cover

Lead Cloud Automation Developer – Sofia, BG

Commis Chef

Senior Medical Writer- London

Senior Manager, Digital Content Strategy

Commis Waiter

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