Job Description

We are currently hiring multiple experienced Principal Medical Writers to support regulatory writing efforts across all phases of clinical development (Phase I–IV) and therapeutic areas. These are remote contract opportunities with flexible hours, ideal for professionals seeking ad hoc, part-time, or full-time engagements.

Responsibilities:

• Author and manage regulatory submission documents including INDs, NDAs, protocols, investigator brochures (IBs), and clinical study reports (CSRs).

• Develop and revise clinical study protocols/amendments, informed consent forms (ICFs), and briefing books.

• Prepare high-quality lay summaries and perform agency response writing for FDA and EMA communications.

• Ability to collaborate cross-functionally with clinical, regulatory, biostatistics, and safety teams to ensure alignment and accuracy.

• Analyze and interpret clinical and nonclinical data across multiple therapeutic areas.

• Ensure all documents comply with FDA, EMA, and ICH guidelines and internal SOPs.

Required Qualifications:

• Bachelor’s degree in life sciences or a related field with at least 5 years of medical writing experience in the pharmaceutical or biotech industry (Advanced degrees such as PhD, PharmD, or MD are preferred but not required).

• Proven track record of authoring and managing regulatory documents for global submissions.

• Demonstrated expertise in agency response writing and briefing book development.

• Strong project management skills.

• Excellent written and verbal communication skills.

• Ability to work independently and manage multiple priorities in a fast-paced environment.

Clinical Resource Network Distinction   

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.

About CRN  

Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn. 

Opportunity Awaits. 

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Job Tags

Hourly pay, Long term contract, Full time, Contract work, Part time, Currently hiring, Flexible hours,

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