Senior Medical Writer

at ICON Strategic Solutions in Boise, Idaho, United States

As a Senior Medical Writer, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Within this program you will thrive within a fast-paced, dynamic study design. As we are fully embedded with this global pharmaceutical client, you will experience a true "one team" approach that provides limitless opportunity to develop through training, mentorship, and support from leadership.

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 visio