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.

Responsibilities

Responsibilities

With minimal guidance from senior members of writing staff prepare clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development using existing systems and processes

Utilize concept of lean authoring and when applicable structured content management text libraries as part of the authoring process

Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines

Develop and maintain project plans using project tracking applications

Coordinate and facilitate document kick-off meetings with writers and cross-functional representatives

Ensure adherence to standard content, lean authoring, and messaging across team members

Ensure communication channels remain open and information is disseminated appropriately

Work as an active member of cross-functional teams

Conduct appropriate literature searches, when required

Ensure compliance with company training and time reporting

The Sr. Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals. The candidate is to demonstrate the following skills:

Critical Competencies

Fluent in reading and writing American English

Demonstrated excellence in focused writing and editing following defined processes and templates. Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions

Communication skills commensurate with a professional working environment

Effective time management, organizational, and interpersonal skills

Customer focus

Comfortable following directions, templates, and structured processes for delivering documents for review and finalization

Able to work independently

Minimum 3 years of writing Regulatory documents supporting global filings

Experienced in authoring multiple CSRs, Protocols, amendments and IBs; experience in writing some

Clinical summary documents preferred

Document Project Management

Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines

Develop timelines in project tracking applications following standard templates

Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion

Adherence to processes

Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements

Scientific Knowledge

Understanding of ICH guidelines and other regional guidelines such as those from the EU and US

Ability to interpret data and apply scientific knowledge to support regulatory document writing (i.e. IB, protocols, amendments, CSR, Clinical summaries)

Ability to use story boards to drive statistical output planning, link data results to key messages, and develop shell documents as starting points for authoring

Understanding of medical practices regarding procedures, medications, and treatment for different disease states

Technology Skills

Expert authoring in MS Word, understanding of MS Word functionality

Experience working in collaborative authoring and review tools

Experience in project tracking applications

Experience working in document management systems; managing workflows; eApproval/esignatures

Experience working with MS Word add-ins that facilitate the management of fonts, styles, references, etc.

Flexibility in adapting to new tools and technology

Capable of training writers/authors on the use of templates, guidelines, and tools

Familiar with Structured Content Management (SCM) and ability to author in an SCM environment using text libraries

Qualifications

Education

MS /PhD (Life Science preferred) or equivalent

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.