Principal Medical Writer

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.

With mínimal 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

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

Work as an active member of cross-functional teams representing Medical Writing

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

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

Ensure communication between members remain open and information is disseminated appropriately

Possible participation in the orientation and coaching of junior team members

Conduct appropriate literature searches, as needed

Participate on Medical Writing department initiatives, as appropriate.

Research regulatory requirements to remain current in the regulatory landscape

Share lessons learned and best practices

Ensure compliance with company training and time reporting

**The Principal 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**

**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

Understanding of clinical development process from program panning to submission, including clinical trial design

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

Oncology and/or Infectious Disease/Vaccines experience highly desired

Regulatory filing experience required

Ability to move across Therapeutic Areas to support business continuity and resource needs

Minimum 5 years in writing Regulatory documents supporting global filings

Experienced in authoring Module 2.7 and 2.5 documents in addition to CSRs, Protocols, amendments and IBs

**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

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**

Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the EU and US

Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science

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

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

Manage messaging for consistency with historical information and in alignment with agreed-upon strategy

Capable of providing insight, alternatives, and suggestions based on previous experiences

Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring

Experience writing protocols, amendments, CSR, and CTD summary documents

**Technology Skills**

Expert authoring in MS Word, understanding of MS Word functionality

Experience in working in collaborative authoring and review tools

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

Experience wor