Medical Writer

POSITION OVERVIEW:

Disc Medicine is seeking an experienced Medical Writer to lead and coordinate the scientific and clinical regulatory writing aspects of documents that will support submission-ready regulatory documents, clinical studies, and scientific publications. The Medical Writer will implement scientific knowledge and writing skills to communicate clinical-science information in a form suitable for the target audience, which includes regulators, clinicians, patients, and others. The Medical Writer will also format documents using StartingPoint, manage document development in Veeva RIM and SharePoint, coordinate literature reviews and library oversight, perform quality control (QC) review and substantive editing, and other medical writing support as needed.

RESPONSIBILITIES:

• Partner and collaborate with clinical and regulatory team members in the preparation of clinical protocols and regulatory documents; participate in study results interpretations and manage the document review/approval process to capture comments and resolve conflicts, including running round-table meetings.
• Communicate and coordinate with line-function team members to gather, organize, and compile information towards the development and planning of writing scientific, clinical, and regulatory documents; communicate deliverables needed, writing process and timelines, and hold team members accountable to agreed-upon dates for deliverables.
• Contribute to timeline planning for regulatory and clinical documents authored by Medical Writing.
• Contribute to preparing manuscripts, conference publications, and slides on research discovery results to support Disc publication strategy.
• Perform QC review as Medical Writing line-function representative and for documents written by other Medical Writing team members.
• Ensure applicable guidelines and regulations are followed in the scientific and clinical writing deliverables, including but not limited to the International Conference on Harmonization (ICH), electronic Common Technical Documents (eCTD) guidelines, content, and templates, as well as document-appropriate QC.
• Verify and share literature references to online library, gather and post literature for submissions, search, and order articles as needed.
• Assist with template modification or creation.
• Stay up to date on current industry practices, compliances, regulations, and company standard operating procedures and policies; assist with writing Medical Writing work instructions, guides, and policies.

 REQUIREMENTS:

• A graduate degree in life sciences or paramedical sciences with 3 years of relevant writing experience; or a bachelor’s degree in life sciences or English/communications with more than 5 years of writing experience in the biotechnology/pharmaceutical industry.
• Strong communication skills and aptitude for revising scientific and clinical information and summarizing findings in a succinct manner.
• Meticulous attention to detail and critical thinking, with ability to correct grammar and provide consistency, clarity, and accuracy.
• Expertise in Microsoft Word and Teams, and advanced-level knowledge of Adobe Acrobat, Veeva, and reference-management software.
• Solid writing skills, with strength in language and English grammar, knowledge of style guides, and word processing/software programs in the Windows environment, with ability and willingness to serve as “super user” and assist Disc colleagues with software.
• Thorough understanding of the drug-development process and expertise with CTD document content and templates.
• Passion for scientific and clinical research knowledge/vocabulary, with “a knack” for working on scientific clinical/medical literature and research data.
• Ability to work as part of a team and independently, as well as the capability to coordinate and collaborate with a variety of people across many time zones.
• Certification from industry-recognized Medical Writing associations is a plus.
• Previous experience with submission publishing, appendices compilation, and electronic submission standards is highly desirable.