Senior Medical Writer

ICON Public Limited Corporation

Remote, United States

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

In this role as a Senior Medical Writer,  you will Perform medical writing tasks, especially medical writing tasks of high complexity and critical to project(s) and strategic area. You will be the specialist for Medical Writing with responsibility for establishing new and improved methods, driving discussions and setting the direction for global knowledge sharing, skill building and ensuring great collaborations with all stakeholders involved.

What does a typical day look like in this Senior Medical Writing role?

  • Performing medical writing tasks:
    • Clinical trial reports (CTRs)
    • Lay summaries of clinical trial results
    • Clinical evaluation plans (CEP) and Clinical evaluation reports (CER)
    • Investigator brochures (IBs)
    • Pediatric investigational plans (PIPs)
    • Clinical summary and overview documents in CTD/eCTD format for regulatory submissions world-wide (including investigational medicinal product dossiers (IMPDs), investigational new drug applications (INDs), marketing authorization applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs))
    • Replies to questions from authorities
    • Deliverables (briefing book, slides) for Advisory Committee Meetings
    • Publications (abstracts, posters and slide presentations for conferences and other scientific meetings, and manuscripts for scientific journals)
    • Protocol, protocol outlines and SI/IC
    • Other ad-hoc documents (e.g. meeting packages)
  • Acting as the Specialist & Subject Matter Expert in medical writing within therapeutic area:
    • Maintain knowledge and competencies within relevant therapeutic and professional areas
    • Drive the sharing of better practices across projects/indications within the therapeutic area
    • Be updated on relevant guidelines and other external requirements in the therapeutic area
    • Represent medical writing in relevant fora based on experience and knowledge in the therapeutic area
    • Provide therapeutic area-specific support and training to other medical writers
    • Establishing new and improved methods within field of expertise
  • Setting direction and driving discussion, ensuring decisions are taken and influence and implement project strategy:
    • Assume role as Project Medical Writer (PMW) and/or Clinical Submission Team Lead (CST)
    • Act as primary stakeholder contact concerning project-specific medical writing issues
    • Reach out to relevant key stakeholders to identify the need, timing and scoping of MW documents
    • Represent MW in relevant project groups (e.g. Clinical Development Team, M&S team, Clinical Submission Team, Publication Planning Group)
    • Review project-related documents and trial-specific documents before trial MW is assigned
    • Develop project specific writing guidance to ensure aligning across MW documents with regards to the level of details and structure of result presentation
    • Inform managers about resource issues (e.g. right qualifications, mandate, allocation) in due time
    • Prioritise and delegate tasks within the project
  • Contributing to knowledge sharing, skill building and good collaboration with stakeholders and colleagues:
    • Act as mentor and trainer for other medical writers on all levels
    • Ensure that project team members know their role and create motivation within the team
    • Represent Clinical Reporting in on-going improvements in cross-functional and global collaborations and sharing of better practices and knowledge
    • Support execution of Clinical Reporting strategy and vision in line with the leadership team
    • Ensure that the strategy within own area is built into the project strategy from an early stage
    • Maintain good working relationships with stakeholders and colleagues

You are:

  • Masters degree with relevant experience; PhD degree preferred
  • ≥5 years experience as Medical Writer or equivalent
  • Pharmaceutical industry understanding
  • Excellent understanding of clinical development and regulatory processes and requirements
  • Business and R&D value chain understanding
  • Excellent communication and presentation skills
  • Experience with a broad range of different medical writing tasks
  • Good mentoring and training skills
  • Demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc
  • Established record of being a proactive team-player and able to deliver on time and with high quality.

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/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.

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Job posted: 2024-04-01

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