Medical Writing Director

Summary

Join Syndax Pharmaceuticals as their Director of Medical Writing! This primarily remote position requires a motivated senior medical writer to lead the creation and management of clinical and nonclinical regulatory documents. You will build operational processes, conduct document reviews, drive continuous improvements, and provide expert review of plain language summaries. The role involves managing outsourced projects, overseeing quality control, and collaborating cross-functionally. Syndax offers a dynamic environment and the opportunity to contribute to innovative cancer therapies.

Requirements

• Bachelor’s degree and 7+ years of hands-on medical writing, with experience at a senior level for 2+ years
• Experience should have been gained directly in pharmaceutical/biotechnology companies and include authoring a wide range of documents (e.g., protocols, IBs, CSRs, briefing books, PIPs, Orphan Drug Applications, documents contributing to global submissions, such as NDAs and MAAs) from inception through completion
• Proven ability to act as lead author on different types of clinical and regulatory documents, including the project management of the document review process
• Highly developed interpersonal skills with demonstrated experience in multi-team management in a matrix environment
• Able to set and communicate goals and strategic vision for the groups within Medical Writing
• Ability to analyze, summarize and interpret clinical data
• Expertise in MS WORD, with the ability to solve technical problems with documents and templates
• Knowledge of FDA and ICH guidelines
• Excellent written and oral communication skills, including functional literacy
• Understanding of the scientific process and clinical research
• Experience working on complex projects within cross-functional teams

Responsibilities

• Build expert operational/business processes for deliverables within Medical Writing, including simplification and improvements of processes
• Conduct review of complex and/or highly confidential documents for internal and external communications
• Develop and drive continuous improvements, including tracking of OKRs (objectives and key results) and metrics
• Provide expert review of plain language summaries ensuring scientific interpretation of data is communicated appropriately for a common/lay audience
• Provide expertise in developing and/or optimizing technologies to augment ways of work within Medical Writing and among the functions with whom Medical Writing collaborates, including resolution of roadblocks and interdependencies
• Advise the Executive Director on resourcing within both Medical Writing and supporting vendors to ensure all deliverables are met with high quality
• Participate in interviewing and selecting new hires
• Write, review, and edit the following regulatory documents: clinical modules of NDAs and MAAs, clinical protocols, clinical study reports, investigator’s brochures, annual reports, DSURs, INDs, IMPDs, and other regulatory documents in conjunction with the project team
• Drive document writing and review processes, by managing document content and presentation of content, and developing timelines in collaboration with team members
• Ensure consistency across documents in a program and supports consistency in company documents, including through the development of document templates
• Guide the team in the generation of documents and take the lead in resolution of document problems
• Work cross-functionally to evolve document preparation and document content practices, to improve quality or efficiency
• Represent medical writing function as an integrated member of clinical study teams
• Coordinate and manage review cycles, incorporates team comments, and leads discussions on document revision and finalization
• Manage outsourced writing projects with contract medical writers as necessary
• Support the development and maintenance of Medical Writing SOPs as well as writing tools such as templates and style manuals, and can provide training within the department and across departments
• Oversee quality control (QC) of documents
• Proactive problem solver, exercising sound judgment and appropriate flexibility within a dynamic environment
• Act as an authoritative resource within specialty area to internal and external resources
• Work effectively with colleagues from other departments in team situations

Preferred Qualifications

• Mentoring and coaching experience
• Experience with the oncology therapeutic area
• Familiarity with industry trends for clinical documents and international dossier preparation, including electronic document submissions
• Working knowledge of the eCTD format

Benefits

Remote work