Principal Medical Writer, Global Medical Writing Job at Deciphera Pharmaceutical

Overview

Principal Medical Writer, Global Medical Writing – Waltham, MA

Be among the first 25 applicants. This is a leadership opportunity for someone with passion and talent in medical writing and an ability to influence leaders and work on fast-paced drug development programs within a dynamic Medical Writing team.

The Role

The Medical Writing team is seeking an experienced, self-motivated Principal Medical Writer to lead across programs/submissions in the growing clinical pipeline. In this high-visibility role, you will independently write and manage clinical study-related documents (including, but not limited to, clinical study protocols, master protocols, Investigator’s brochures, and clinical study reports) and lead cross-functional teams in developing regulatory submission documents, regulatory response documents, and other IND/CTA or global regulatory submission documents. The position reports to the Sr. Director, Global Medical Writing.

Responsibilities

• Medical Writing lead for one or more clinical programs, planning, developing, and implementing content strategy for clinical and regulatory documents.
• Represent Medical Writing on cross-functional clinical, regulatory, and submission teams; participate in NDA/MAA/IND submission planning and documentation.
• Author and manage the preparation of clinical documents and other tasks within established timelines with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
• Drive document strategies and messages collaboratively with project team subject matter experts.
• Maintain cutting-edge knowledge of current developments in the field and related technologies.
• Incorporate process improvements that align with R&D needs.
• Plan and coordinate work with in-house Medical Writing team and outside CROs; mentor junior team members.
• Strong team player and change agent to reinforce Deciphera’s cultural values.
• Experience performing medical literature searches and reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings as needed.

Qualifications

• PhD or equivalent plus 5+ years of experience or Bachelor/Master plus 10+ years of experience.
• Expert knowledge of and experience in preparing high-quality clinical and regulatory documents.
• Knowledge of clinical trial disclosure.
• Submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in preparation of summary documents.
• Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
• Strong organizational and prioritization skills for managing multiple concurrent documents.
• Proficiency with eCTD Starting Point templates, Smart Sheet, databases, MS Office (Teams, Outlook, Word, Excel, PowerPoint), SharePoint, Veeva Vault, and related tools.
• Oncology, immunology, and/or neurology experience is highly preferred.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, and more.
• Generous parental leave and family planning benefits.
• Opportunities for personal and professional growth.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. Completing the confidential survey at the end of the application is optional and will not affect your opportunity for employment. This information is confidential and used for reporting purposes only. We are committed to making all hiring decisions on a non-discriminatory basis.