Senior Medical Writer

ICON plc; United Kingdom; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Medical Writer to join their team. This role involves independently authoring various regulatory documents for a top pharmaceutical client. The position is home-based, offering opportunities for professional growth and a range of competitive benefits.

Benefits

Health Insurance

Flexible Benefits

Life Assurance

Employee Assistance Programme

Qualifications

• Experienced in writing regulatory documents for pharma or CRO.
• Submission experience is preferred.

Responsibilities

• Author study-level documents like protocols and clinical study reports.
• Lead discussions and ensure adherence to timelines.

Skills

Communication

Problem-Solving

Facilitation

Job 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 fully dedicated to a Top-5 pharmaceutical company. While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer-term career.

This role is home based in the UK or Europe

What you will be doing:

• Independently author most study-level documents at simple to complex levels, for example:
• Protocol, protocol outlines
• Subject Information/Informed Consent
• Clinical study reports (CSRs)
• Lay summaries of clinical trial results
• Investigator brochures (IBs).
• Provide support to more experienced writers with the preparation of submission and other complex clinical documents.

• Capable of interpreting and summarizing data.
• Drive discussions, ensure decisions are taken and incorporate project strategies in documents.
• Lead meetings and drive decisions concerning project/trial-specific medical writing issues.
• Responsible for all medical writing aspects of task finalization including stakeholder alignment, coordination, and adherence to timelines.

You are:

• Experienced in writing regulatory documents for pharma or CRO, such as protocols, CSRs, IBs
• Submission experience (or components of submission)
• Highly pro-active team player.
• Skilled in building and maintaining good working relationships with stakeholders and colleagues.
• Strong engagement with stakeholders to understand and align on the purpose/strategy, timing, and scope of MW tasks.
• Strong facilitation, communication and problem-solving skills to effectively manage interactions with all stakeholders and drive decision making.
• Represent MW in relevant project groups (e.g., trial squads, M&S team, Clinical Submission Team, Publication Planning Group).
• Contribute to knowledge sharing, skill building, and good collaboration with stakeholders and colleagues.
• Can work independently and demonstrate resourcefulness (refers to SOPs, guidance documents, and training before reaching out to others for answers to questions relating to medical writing procedures, etc.).

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, inclusion & belonging are fundamental to our culture and values. 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, colour, 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.