Manager, Medical Writing Quality Control

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. 

COMPANY OVERVIEW:

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

POSITION OVERVIEW:

Disc Medicine is seeking a Manager, Medical Writing QC to perform and coordinate quality control (QC) review and editing activities, maintain the QC calendar and tracker, assign QC projects to vendors and incorporate edits, format documents, load and manage documents in Veeva and SharePoint, acquire literature and assist with managing the shared library, and other medical writing operational support for regulatory documents, clinical studies, and Medical Affairs publications. The Manager, Medical Writing QC will implement document management and editorial skills to help streamline all written communications.

RESPONSIBILITIES:

• Working with Medical Writing, revise documents for adherence to style guidelines, consistency, and submission compliance, including formatting, corrections, annotations, source verification, and all levels of QC and editing as applicable.
• Collaborate with Medical Writing and other clinical and regulatory team members in the preparation of clinical and regulatory documents; participate in the document-review process to consolidate comments and resolve conflicts.
• QC and edit manuscripts, abstracts, and other conference materials related to publications strategy.
• Contribute to timeline creation and adhere to review timelines.
• Verify, gather, and share literature references to library, gather and post literature for submissions, coordinate searches, and order articles as needed.
• Ensure applicable guidelines and regulations are followed in the scientific and clinical writing deliverables, including but not limited to the International Council for Harmonisation (ICH), Common Technical Documents (CTD) guidelines, content, and templates, as well as QC documentation.
• Assist with template modification or creation.
• Assist with development of Medical Writing standard operating procedures (SOPs) and policies, internal guides, project checklists, and training materials.
• Stay up to date on current industry practices, compliances, regulations, SOPs, and company goals.

 REQUIREMENTS:

• A graduate degree in life sciences or paramedical sciences with five years of relevant editing and QC experience in a Medical Writing environment; or a bachelor’s degree in life sciences or English/communications with more than five years of editing and QC experience in the biotechnology/pharmaceutical industry.
• Certification from industry-recognized Medical Writers associations (eg, AMWA, BELS) is preferred.
• 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.
• Solid editing, technical, and analytical skills, with strength in language and English grammar, knowledge of style guides, and word processing/software programs in the Windows environment.
• 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.
• Interest in expanding medical writing skills.

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment. 

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.