Senior 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.

The Sr. Medical Writer, Medical Writing may independently serve as primary author of complex writings, e.g. scientific or business publications, important clinical documents (e.g., pivotal Phase 3 protocols and reports) and lead BLA/MAA submission document development. The incumbent may provide medical writing project management support for multiple compounds and multiple projects throughout clinical development phases.  The Sr. Medical Writer, Medical Writing handles more complex medical writing assignments than those of less senior medical writers. Typical duties would include substantive preparation, editing, and review of regulatory and/or clinical documents, project management/medical writer-allocation planning across research and development projects for the MW team, researching and use of published study reports for various investigational compounds for multiple therapeutic indications, independently preparing medical writing documents as needed, and coordinating the publication of key nonclinical, early clinical, and clinical scientific data through peer-reviewed journals and forums.

• Writes, reviews, and edits clinical and/or regulatory documents (e.g., protocol, protocol amendments, preclinical and clinical study reports, Investigator’s Brochures, IB addendums, package inserts, clinical and non-clinical modules of INDs, NDAs, and MAAs, Briefing Books, annual reports, DSURs, IMPDs) and other documents in collaboration with cross-functional area teams and per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the National Institute of Health (NIH), and regulatory guidance’s/standards.
• May also prepare publications (scientific manuscripts, abstracts, poster presentations, oral presentations).
• Represents medical writing function as an integrated member of clinical study teams.
• Drives document writing and review processes.
• Develops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members.
• Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization.
• Develops and maintains SOPs for the function and writing tools, such as templates and style manuals, and provides training within the department and across departments.
• Performs Quality Control (QC) for all deliverables by self and other medical writers as a critical component of the medical writing process.
• Identifies recurring QC issues and makes recommendations to line manager for improvement (revisions to SOPs, recommendations for individual training, etc.); implements approved ideas.
• Assigns tasks to other Medical Writers based on each writer’s unique knowledge and skills, while also ensuring appropriate workload distribution in order to meet project deadlines.
• May assist the Director with oversight and review the work of other medical writers to ensure adherence to SOPs and approved processes; manages outsourced writing projects with contract medical writers as necessary.
• Collaboratively contributes to regulatory medical writing tasks across functional teams and projects, providing relevant guidance and direction for less senior medical writers as needed.
• Develops and drives detailed project timelines according to team-specified deadlines in accordance with current medical writing team processes.
• Works to develop regulatory document templates, formatting, and guidelines for clinical documentation.
• May function as a medical writing liaison between the medical writer team and nonclinical/clinical cross-functional study teams.

• BA/BS required, preferably in a related scientific discipline.
• Advanced scientific degree (MS, PharmD, PhD) is preferred.
• 5+ years of healthcare experience is required.
• 3+ years pharmaceutical or pharmaceutical Clinical Research Organization (CRO) medical writing experience is required, ideally experience that is well-documented.
• Hands-on Clinical Research experience is a plus.
• Experience in a Sr. Medical Writing or lead role, including project/resource allocation experience. Ability to draw on broad expertise to recommend new company SOPs (or revisions to existing ones) to continually improve internal processes.
• Outstanding team player. Can work as a leader and a member in a collaborative and supportive role; demonstrates leadership through assigning/managing the work of other writers and developing people through mentoring.
• Knowledge of clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH, NIH), AMA writing style, use of Word templates, and familiarity with GCP guidelines. An attentive, fast learner who is willing to continue to gain regulatory MW expertise and implement MW and client working processes and SOPs.
• Outstanding interpersonal, written and oral communication skills, an ability to work in collaboration with a cross-functional study team, able to establish rapport with all functional leaders, experts and colleagues.
• Ability to conceptually organize and analyze data, interpret, and synthesize complex clinical and nonclinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences.
• Ability to contribute to new or revised company SOPs to continually improve internal processes.
• Ability to multitask while driving towards critical deadlines on all projects.
• Superior attention to detail. Ability to identify and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy in US- and UK-based English.
• Superior computer skills.
• Experienced with MS Office (Word, Excel, PowerPoint, Outlook), MS Project and database applications. Preferably familiar with current electronic authoring, document management and electronic regulatory submissions.

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.