Director, Global Medical Writing

Deciphera Pharmaceuticals•Waltham, MA

2d•$175,000 - $215,000•Remote

About The Position

Deciphera’s Medical Writing team is seeking an experienced, self-motivated Director, Global Medical Writing with knowledge of the current medical writing landscape. The Director will serve as lead writer across programs and submissions in the growing clinical pipeline, independently writing and managing clinical study-related documents such as clinical study protocols, master protocols, Investigator’s Brochures, and clinical study reports. The role also leads cross-functional teams developing regulatory submission documents, regulatory response documents, and other IND/CTA or global regulatory submission documents. The position reports to the Senior Director, Global Medical Writing. The Director will lead Medical Writing for one or more clinical programs, guiding content strategy and representing Medical Writing on clinical, regulatory, and submission teams, including active participation in NDA/MAA/IND planning and documentation. The role coordinates internal writers and outside CROs, reviews medical writing deliverables and other materials as needed, and contributes to company-wide initiatives. It includes managing and mentoring 1–2 direct reports, with future oversight of writing across a therapeutic area. This is a remote position. The estimated annual base salary range is $175,000–$215,000. Deciphera’s total rewards package includes an annual performance bonus, long-term incentive plan, benefits, and other incentive compensation plans where applicable.

Requirements

Advanced degree (MS or Ph.D.) in a relevant scientific field.
Minimum of 8–10 years of medical writing experience.
Expert knowledge of and experience preparing high-quality clinical and regulatory documents.
Knowledge of clinical trial disclosure.
Experience authoring regulatory and clinical documents for global submissions, including strong submission experience across ICH regions (NDA, NDS, MAA, IND), with active contribution to planning and preparation of summary documents.
Excellent verbal and written communication skills, with attention to detail in consistency, grammar, syntax, and accuracy.
Strong organizational and prioritization skills for managing multiple concurrent documents.
Proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software, MS Office applications (Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please Review.
Ability to manage multiple concurrent projects and meet project timelines.
Experience performing medical literature searches.

Nice To Haves

Ph.D. degree.
Oncology, immunology, and/or neurology experience.

Responsibilities

Lead Medical Writing for one or more clinical programs and plan, develop, and implement content strategy for clinical and regulatory documents.
Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and participate in NDA/MAA/IND submission planning and documentation.
Author and manage clinical documents and other assigned tasks to established timelines and quality standards, following regulatory and internal guidelines, styles, and processes.
Collaboratively drive document strategies and messages with relevant project-team subject matter experts.
Maintain current knowledge of developments in the field and related technologies.
Incorporate process improvements and changes aligned with R&D needs.
Plan and coordinate work with the in-house Medical Writer team and outside CROs.
Participate in company-wide initiatives, such as leading protocol template working groups or IB standardization across programs.
Review medical writing deliverables and, as needed, statistical analysis plans, tables, figures, and listings.
Manage and mentor 1–2 direct reports, with future oversight of writing across a therapeutic area.