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Principal Medical Writer, Global Medical Writing

Deciphera Pharmaceuticals

Waltham, MA
Full Time
Senior
121k-159k
17 days ago

Job Description

About the Role

Principal Medical Writer, Global Medical Writing at Deciphera Pharmaceuticals is an exciting leadership role within a dynamic medical writing team. The position offers the opportunity to influence company leaders, work on fast-paced drug development programs, and contribute to an emerging success story driven by a commitment to patients and employees. The role involves independently managing and writing clinical study-related documents, leading cross-functional teams, and supporting regulatory submissions in a high-visibility environment.

Key Responsibilities

  • Medical Writing lead for one or more clinical programs, overseeing the planning, development, and implementation of 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 the preparation of clinical documents such as clinical study protocols, master protocols, Investigator's brochures, and clinical study reports.
  • Lead development of regulatory submission documents, regulatory response documents, and other IND/CTA or global regulatory submission documents.
  • Drive document strategies and messages collaboratively with project team subject matter experts.
  • Maintain current knowledge of developments in the field and incorporate process improvements.
  • Review medical writing deliverables, statistical analysis plans, tables, figures, and listings as needed.
  • Plan and coordinate work with in-house Medical Writer team and outside CROs.
  • Mentor junior team members, providing guidance and expertise in medical writing.
  • Perform medical literature searches and ensure high-quality, accurate, and compliant documentation.

Requirements

  • Advanced degree (MS or Ph.D.) in a relevant scientific field; Ph.D. preferred.
  • Minimum of 5-8 years of medical writing experience.
  • Expert knowledge of and experience in preparing high-quality clinical and regulatory documents.
  • Knowledge of clinical trial disclosure and submission processes across ICH regions (NDA, NDS, MAA, IND).
  • Experience in preparing summary documents and contributing to regulatory submissions.
  • Excellent verbal and written communication skills with attention to detail.
  • Strong organizational and prioritization skills for managing multiple projects.
  • Proficiency with eCTD Starting Point templates, Smart Sheet, databases, MS Office tools (Teams, Outlook, Word, Excel, PowerPoint, SharePoint), Veeva Vault, and Please Review Oncology, immunology, and/or neurology experience is highly preferred.

Nice to Have

  • Experience in oncology, immunology, and/or neurology.

Qualifications

  • Doctoral degree (Ph.D.) or Master's degree in a relevant scientific field.

Benefits & Perks

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

Working at Deciphera Pharmaceuticals

Deciphera is committed to equal employment opportunity and values diversity. The company emphasizes an outstanding culture and opportunities for personal and professional growth, fostering a mission-driven environment focused on improving the lives of people with cancer.

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Job Details

Posted AtJul 9, 2025
Job CategoryContent Marketing
Salary121k-159k
Job TypeFull Time
ExperienceSenior

Job Skills

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About Deciphera Pharmaceuticals

Website

deciphera.com

Location

Waltham, MA

Industry

Pharmaceutical Preparation Manufacturing

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