JUMP TO CONTENT

Principal Medical Writer

  1. UK
2024-114872
  1. Medical Writing
  2. ICON Strategic Solutions
  3. Remote

About the role

As a Principal Medical Writer you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors ICON's commitment to career development.


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.

 


  • Bachelor’s degree in science, health profession required
  • At least 7 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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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

Principal Medical Writer

Salary

Location

Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland

Department

Medical Affiars & Medical Writing Roles

Location

Belgium

Denmark

France

Germany

Netherlands

Spain

Switzerland

UK

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Medical Writing

Job Type

Permanent

Description

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

Reference

2023-103952

Expiry date

01/01/0001

Natalia Roth

Author

Natalia Roth
Read more Shortlist Save this role
Principal Medical Writer

Salary

Location

Canada

Department

Medical Affiars & Medical Writing Roles

Location

Canada

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Medical Writing

Job Type

Permanent

Description

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

Reference

2024-114552

Expiry date

01/01/0001

Brendan Hoey

Author

Brendan Hoey
Read more Shortlist Save this role
Senior Medical Writer - Canada Remote

Salary

Location

Canada

Department

Medical Affiars & Medical Writing Roles

Location

Canada

Remote Working

Remote

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

2024-115021

Expiry date

01/01/0001

Brendan Hoey

Author

Brendan Hoey
Read more Shortlist Save this role
Senior Medical Writer

Salary

Location

Europe

Department

Medical Affiars & Medical Writing Roles

Location

Any EMEA Location

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. As a Senior Medical Writer you will be suppo

Reference

2024-114938

Expiry date

01/01/0001

Natalia Roth

Author

Natalia Roth
Read more Shortlist Save this role
Senior Medical Writer

Salary

Location

Europe, Germany

Department

Medical Affiars & Medical Writing Roles

Location

Any EMEA Location

Germany

Business Area

ICON Strategic Solutions

Job Categories

Medical Writing

Job Type

Permanent

Description

As a Senior Medical Writer you will join ICON plc - a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsou

Reference

2024-114507

Expiry date

01/01/0001

Natalia Roth

Author

Natalia Roth
Read more Shortlist Save this role
Principal Medical Writer

Salary

Location

United Kingdom, Europe

Department

Medical Affiars & Medical Writing Roles

Location

Any EMEA Location

UK

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Medical Writing

Job Type

Permanent

Description

As a Principal Medical Writer  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be fully dedicated to a Top-5 p

Reference

2024-113477

Expiry date

01/01/0001

Natalia Roth

Author

Natalia Roth
Read more Shortlist Save this role

Browse popular job categories below or search all jobs above