JUMP TO CONTENT

Principal Medical Writer

  1. Any EMEA Location, UK
2025-118037
  1. Medical Writing
  2. ICON Strategic Solutions
  3. Remote

About the role

As a Senior or Principal you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.


What you will be doing:

Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents. As necessary, may assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission. Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area. Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation, including international regulatory guidance and requirements for content and format, work requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.

 

  • Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
  • Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
  • Provides review and substantive editing of contributions, and ensures resolution of issues.
  • Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to  regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Sponsor requirements and processes across development programs.
  • Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
  • Acts as a key Medical Point of contact for clinical regulatory stragegy
  • As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
  • Provides leadership on functional teams that address requirements or issues related to document preparation and production.
  • The Principal Medical Writer is seen as an expert in medical writing and performs work independently with minimal supervision.

#LI-NR1

#LI-Remote


  • Bachelor’s degree in science, health profession required
  • At least 5 years of experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
  • Experience as lead writer for key documents included in major international regulatory submissions required like Clinical study reports, IBs, Protocols 
  • Experience managing writing activities for a major  international regulatory submission preferred.

 

Knowledge and Skills: 

  • Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
  • Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs).
  • Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
  • Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers

 

 


What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others



Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits


https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

List #1

Day in the life

Similar jobs at ICON

Manager, Medical Writing

Salary

Location

Spain, France, Germany, United Kingdom

Department

Medical Affiars & Medical Writing Roles

Location

France

Germany

Spain

UK

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Medical Writing

Job Type

Permanent

Description

As a Manager Medical Writing you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. OBJECTIVES:  Leads project teams responsib

Reference

2025-119084

Expiry date

01/01/0001

Natalia Roth

Author

Natalia Roth
Read more Shortlist Save this role
Senior Medical Writer

Salary

Location

Europe, Switzerland, United Kingdom, Germany

Department

Medical Affiars & Medical Writing Roles

Location

Any EMEA Location

Germany

Switzerland

UK

Remote Working

Remote

Area of interest

Europe ICON Full Service & Corporate Support Talent Acquisition

Business Area

ICON Strategic Solutions

Job Categories

Medical Writing

Job Type

Permanent

Description

As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. 

Reference

2025-118963

Expiry date

01/01/0001

Natalia Roth

Author

Natalia Roth
Read more Shortlist Save this role
Senior Medical Editor

Salary

Location

United States

Department

Medical Affiars & Medical Writing Roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Medical Writing

Job Type

Permanent

Description

As a Senior Medical Editor you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-119065

Expiry date

01/01/0001

Brendan Hoey

Author

Brendan Hoey
Read more Shortlist Save this role
Medical and Scientific Writer II

Salary

Location

Ireland, Dublin

Department

Full Service - Development & Commercialisation Solutions

Location

Dublin

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Medical Writing

Job Type

Permanent

Description

We are currently seeking a Medical and Scientific Writer II to join our diverse and dynamic team. As a Medical and Scientific Writer II at ICON, you will play a pivotal role in the development and pre

Reference

JR129679

Expiry date

01/01/0001

Sophia Cairns

Author

Sophia Cairns
Read more Shortlist Save this role
Principal Medical Writer

Salary

Location

Germany, Mannheim

Department

Full Service - Early Clinical and Bioanalytical Solutions

Location

Mannheim

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Medical Writing

Job Type

Permanent

Description

We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality reg

Reference

JR129191

Expiry date

01/01/0001

Sophia Cairns

Author

Sophia Cairns
Read more Shortlist Save this role
Senior Medical Writer

Salary

Location

Romania, Bucharest

Location

Bucharest

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Medical Writing

Job Type

Permanent

Description

We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medi

Reference

JR129492

Expiry date

01/01/0001

Sophia Cairns

Author

Sophia Cairns
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above