Seeking an experienced Principal Regulatory Medical Writer to lead the development of clinical and regulatory documents and manage projects from initial planning through final submission.

• Pay range:  $85-115hrly

Responsibilities:

• Write and manage complex clinical and regulatory documents, including protocols, clinical study reports, investigator brochures, Common Technical Document content, regulatory responses, and submission documents.
• Lead document planning, timelines, cross functional reviews, quality control, approvals, and final delivery.
• Partner with Clinical, Regulatory, Safety, Statistics, Clinical Pharmacology, Nonclinical, CMC, and other functional teams.

Required Qualifications:

• 6 or more years of pharmaceutical or biotechnology regulatory or medical writing experience.
• 4 or more years of regulatory document project management experience.
• Strong clinical and regulatory document writing experience. Nonclinical and CMC writing experience is highly preferred.
• Strong project management, organization, and communication skills with the ability to independently drive multiple documents and timelines.
• Bachelor's degree required. Advanced degree preferred.

If you meet the required qualifications and are interested in this role, please apply today.

The Solomon Page Distinction

Our teams, comprised of subject matter experts, develop an interest in your preferences and goals and we act as an advisor for your career advancement. Solomon Page has an extensive network of established clients which allows us to present opportunities that are well-suited to your respective goals and needs – this specialized approach sets us apart in the industries we serve.

About Solomon Page

Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit: solomonpage.com and connect with us on Facebook, and LinkedIn.

Opportunity Awaits.

#LI-MB7