Lead Analyst, Oncology Regulatory Medical Writing

4 weeks ago

Birch Run, Michigan, United States J&J Family of Companies Full time
Position Overview

Senior Analyst, Oncology Regulatory Medical Writing
At J&J Family of Companies, our mission is to enhance the quality of life for individuals by addressing significant health challenges. We are dedicated to the discovery and development of innovative solutions for complex medical conditions.


Our Integrated Data Analytics & Reporting (IDAR) team is currently seeking a Senior Analyst to contribute to our Oncology division.

This role may offer flexibility for remote work arrangements, subject to approval.

Key Responsibilities

  • Draft and finalize essential clinical documents, including clinical study reports, investigator's brochures, study protocols, and regulatory submissions.
  • Facilitate cross-functional document planning and review sessions, collaborating with peers and other departments.
  • Mentor junior writers in document planning and content development, providing guidance and peer review as necessary.
  • Establish timelines and strategies for document preparation in alignment with internal protocols, with guidance from management.
  • Serve as the primary contact for medical writing activities within the clinical team, overseeing planning and strategy for assigned projects.
  • Stay informed about industry standards, company policies, and regulatory requirements.

Qualifications

Education:
A degree from a recognized university is required; a Master's or PhD is preferred.

Experience and Skills:

Ideal candidates will possess:
  • A minimum of 6 years of relevant experience in the pharmaceutical or scientific field, with at least 4 years in medical writing.
  • Strong ability to interpret and present complex statistical and medical information accurately.
  • Experience in the oncology therapeutic area is highly desirable.
  • Exceptional attention to detail and strong communication skills.
  • Proven leadership capabilities in project and process management.
  • A demonstrated ability to build effective relationships with cross-functional teams.

Compensation and Benefits:
The anticipated compensation for this role is competitive and performance-based, with eligibility for an annual performance bonus and a comprehensive benefits package, including health insurance, retirement plans, and paid time off.

J&J Family of Companies is committed to fostering an inclusive workplace and encourages applications from all qualified individuals.

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