Job Description

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Guides medical writing document preparation, including coordination of assignments to contract writers, review and substantive editing of documents. 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 US and international regulatory guidance and requirements for content and format, requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. Leverages internal and external resources to achieve quality, timely and cost-effective compound level submission deliverables. May participate in the training, guidance, and mentoring of the medical writing junior staff and may oversee junior staffs' deliverables.

Responsibilities

• 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 FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and processes across development programs.
• Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
• 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.

Qualifications

EDUCATION, EXPERIENCE AND SKILLS:

• Bachelor's degree in science, health profession, or journalism 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 US and/or international regulatory submissions required
• Experience managing writing activities for a major US or international regulatory submission (project or people management) 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 FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
• Ability to understand Sponsor guidelines and requirements related to the preparation and production of regulatory documents and submissions.
• 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.
• Knowledge of team dynamics and ability to function as a team leader.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.