Full-Time

Principal Medical Writer

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10,001+ employees

Global drug and device development services

No salary listed

Remote in UK + 5 more

More locations: Barcelona, Spain | Paris, France | Reading, UK | Frankfurt, Germany | Florence, Metropolitan City of Florence, Italy

Remote

Must have the legal right to work in the country where the role is based.

Bachelor's, Master's

Category
Content & Writing (1)

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Requirements
  • A Bachelor's degree in a life science discipline is required.
  • At least 6 years of medical writing experience in the biopharmaceutical or contract research organization industry is required.
  • Regulatory writing experience with Clinical Study Reports, Investigator's Brochures, and Protocols is required.
  • Proficient understanding and knowledge of domestic and international regulatory requirements is required.
  • Proficiency in organizing and communicating clinical information is necessary.
  • Strong communication, organizational, time management, and project management skills are required.
  • Employment requires the legal right to work in the country where the role is based.
Responsibilities
  • Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards, processes, and applicable client authoring standards, while adhering to study or project timelines and corporate objectives.
  • Manage medical writing projects, including developing timelines with study or project teams as necessary and communicating with cross-functional team members to maintain awareness of review cycles and expectations.
  • Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes needed to complete regulatory documents.
  • Review other documents associated with assigned projects, including Protocols and Statistical Analysis Plans, as appropriate.
Desired Qualifications
  • A Master's degree in a life science discipline is preferred.
  • Experience leading submissions in addition to other document experience is preferred.
  • Oncology experience is a plus.
  • Knowledge of therapeutic areas across all phases of clinical development is desired.

Provides consulting, development, and commercialization services for drugs and medical devices through a global network to help clients accelerate development and bring products to market. A global team of experts in 53 countries offers end-to-end support across strategy, development, regulatory, manufacturing, and market access to reduce time to market, lower costs, and improve quality. The company differentiates itself with its large global presence, clear focus on speed and cost, and extensive experience across therapeutic areas. Its goal is to help clients accelerate the development of life-saving drugs and devices by delivering high-quality information, solutions, and performance.

Company Size

10,001+

Company Stage

IPO

Headquarters

Ireland

Founded

1990

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Simplify Jobs

Simplify's Take

What believers are saying

  • ICON's Q2 2026 backlog reached $23.4 billion, up 3.0% sequentially.
  • Phase III opportunities formed roughly 50% of Q2 2026 pipeline, improving revenue quality.
  • August 2026 refinancing replaced secured debt and released collateral, strengthening balance-sheet flexibility.

What critics are saying

  • ICON restated 2023-2025 revenue after finding overstatements and material weaknesses in controls.
  • SEC scrutiny and shareholder lawsuits after February 2026 disclosures threaten management distraction through 2027.
  • If sponsors distrust ICON's numbers, CRO bids and renewals deteriorate, risking franchise impairment.

What makes Icon unique

  • ICON's Orbis platform now embeds Claude across trial planning, enrollment, protocol, and client integration.
  • ICON combines 40,200 employees and 55-country delivery with deep clinical development expertise.
  • ICON's bookings engine delivered $3.68 billion gross bookings and 1.51x book-to-bill in Q2 2026.

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Benefits

Health Insurance

Paid Vacation

401(k) Retirement Plan

Mental Health Support

Life Insurance

Flexible Work Hours

Growth & Insights and Company News

Headcount

6 month growth

29%

1 year growth

31%

2 year growth

31%
StreetInsider
Aug 6th, 2026
ICON prices $2.15B in senior unsecured notes to refinance debt

ICON plc has priced $2.15 billion in senior unsecured notes through its subsidiary, ICON Investments Six Designated Activity Company. The offering comprises three tranches: $500 million of 5.064% notes due 2029, $1.0 billion of 5.421% notes due 2031, and $650 million of 5.995% notes due 2036. The notes will be guaranteed by ICON on a senior unsecured basis. The offering is expected to close on 13 August 2026, subject to customary closing conditions. ICON intends to use proceeds to repay all outstanding borrowings under its bridge facility credit agreement, repay all outstanding senior secured term loans, and redeem its 5.809% Senior Secured Notes due 2027. Upon repayment, collateral securing ICON's revolving credit facility will be automatically released.

Yahoo Finance
Aug 5th, 2026
ICON shares jump 33% in three months on $29.7B backlog and improving biotech demand

ICON Public Limited Company shares rose 33.2% over three months amid strengthening recovery signs in clinical research demand. Request-for-proposal flow increased 22% sequentially in Q2 2026, with Phase III programmes representing about 50% of opportunity volume. Gross bookings reached $3.68 billion, up 24.1% year-over-year, whilst net business wins totalled $3.12 billion. The book-to-bill ratio stood at 1.51X. Backlog grew 3% sequentially to $23.4 billion, improving revenue visibility. However, second-quarter adjusted EBITDA declined 21.7% year-over-year to $327.2 million, whilst adjusted earnings fell to $2.56 per share from $3.52. Higher pass-through revenues supported sales but pressured margins. Analysts expect 2026 revenues to decline 1% and earnings to fall 15.3% year-over-year.

Business Wire
Jul 31st, 2026
ICON shareholders approve all resolutions at annual general meeting

ICON plc, a clinical research organisation, announced that shareholders approved all resolutions at its Annual General Meeting held on 31 July 2026. The resolutions, which were sent to shareholders on 26 June 2026, included the re-election of several board members and the election of new directors. The approved resolutions covered various corporate governance matters, including authorising the company to allot shares, disapply statutory pre-emption rights, and make overseas market purchases of shares. Shareholders also authorised the price range for reissuing treasury shares. Headquartered in Dublin, ICON employed approximately 40,200 people across 99 locations in 55 countries as of 30 June 2026. The company provides clinical development and commercialisation solutions to pharmaceutical, biotechnology, medical device, and public health organisations worldwide.

Yahoo Finance
Jul 28th, 2026
ICON partners with Anthropic to deploy Claude AI across clinical trial lifecycle

ICON plc has announced a multi-year collaboration with Anthropic to integrate Claude's AI capabilities throughout the clinical trial lifecycle. The partnership will advance ICON's Orbis platform, developing four production capabilities: site intelligence and study planning, predictive intelligence for enrolment risks, protocol optimisation, and ecosystem integration. ICON will deploy Claude across its organisation through role-based implementations, including Claude Code for developers and Claude Science for scientific teams. The collaboration will strengthen Orbis's intelligence layer, connecting ICON's expertise and data across trials. Chief Executive Officer Barry Balfe stated the partnership aims to accelerate clinical trials by combining ICON's clinical development expertise with Anthropic's frontier AI capabilities, helping sponsors make better decisions and execute studies with greater precision.

Contract Pharma
Jul 28th, 2026
ICON to deploy Claude AI across clinical trial lifecycle.

ICON to deploy Claude AI across clinical trial lifecycle. Multi-year collaboration will apply Claude's AI capabilities to trial planning, enrollment risk detection, protocol optimization and client integration. July 28, 2026 Associate Editor Editor's Take: From drug formulation to workflow automation, artificial intelligence (AI) is transforming life sciences. ICON is the latest company to expand its adoption of AI. ICON plc has entered a multi-year collaboration with Anthropic to bring Claude's AI capabilities across the clinical trial lifecycle - further advancing ICON's digital innovation and AI strategy, and building on Orbis, ICON's secure, governed, agentic AI platform. Through this collaboration, ICON will work closely with Anthropic's Life Sciences research team to explore and apply technologies with the goal of accelerating innovation across clinical development. Barry Balfe, CEO of ICON plc, said, "We are determined to lead AI acceleration of clinical trials. Working with Anthropic gives us direct access to frontier AI capability and the people who build it. By combining ICON's clinical development expertise, global delivery model and proprietary trial intelligence with Anthropic's frontier AI capabilities, we believe we can help sponsors make better decisions earlier, execute studies with greater precision and ultimately accelerate the delivery of medicines to patients." How Claude will be deployed. With support from Anthropic, ICON will develop four production capabilities within Orbis: * Site intelligence and study planning: powering ICON's OneSearch and OnePlan tools with frontier model reasoning to sharpen site selection and study feasibility. * Orbis predictive intelligence: enabling real-time detection of enrollment risks, trends and operational signals across active studies. * Protocol optimization: applying AI to protocol design and scenario modelling to reduce amendments and accelerate study startup. * Ecosystem integration: integrating ICON's clinical expertise into client systems, allowing them to securely access ICON's insights directly within Claude. ICON will deploy Claude across the organization through a targeted, role-based rollout: Claude Code for developers, Claude for knowledge teams, and Claude Science for scientific and clinical teams for maximum value creation. "AI holds real potential to address long-standing challenges in clinical development and make a measurable difference for patients," said Pip White, Head of Ireland, UK and Northern Europe, Anthropic. "Far too often, the barrier to getting medicines to patients faster is operational, not scientific. Take study enrollment as an example - it's one of the biggest bottlenecks in clinical development and causes delays in up to 80% of trials. This is exactly the kind of operational challenge that ICON's trial-delivery expertise, paired with Claude, is well suited to address." Earlier this year, BMS announced plans to deploy Claude across its research, clinical development, manufacturing, commercial, and corporate functions.