Principal Strategic Medical Writer (Oncology)

Role Summary

Principal Strategic Medical Writer (Oncology) responsible for leading complex clinical and regulatory documents, coordinating cross-functional activities, and ensuring timely delivery of high-quality medical writing deliverables in support of oncology programs.

Responsibilities

• Serve as a lead on complex clinical & regulatory documents.
• Work closely with the team(s) on document authoring & content strategies.
• Coordinate review, approval, & quality control of other functions involved in the production of clinical & regulatory projects.
• Communicate deliverables needed, writing process, & timelines to team members.
• Hold team members accountable to agreed-upon project dates.
• Work independently with Regulatory Quality Assurance to address inquiries & draft responses.

Qualifications

Education & Experience

• Must have a Bachelor’s degree in a scientific discipline or foreign education equivalent & 5 years of academic &/or industry medical writing experience.
• Of experience required, must have 3 years with each of the following:
  • preparing & presenting written & oral scientific presentations to peers, business stakeholders & management;
  • interpreting statistical data to prepare written medical and scientific reports for regulatory bodies;
  • clinical regulatory writing experience following regulations ICH & FDA regulatory requirements;
  • working with stakeholders in drug development, clinical research, study designs, & biostatistics to author clinical regulatory documents;
  • performing medical writing in the bio-pharmaceutical industry; &
  • managing project delivery timelines.

Skills

• Strong written and oral communication skills for scientific and regulatory audiences.
• Ability to work with cross-functional teams and manage multiple regulatory documents simultaneously.
• Proficiency in clinical regulatory writing and adherence to ICH & FDA requirements.

Education

• Bachelor’s degree in a scientific discipline or foreign education equivalent.

Additional Requirements

• 100% Telecommuting permitted.