Senior Regulatory Medical Writer, Client-Embedded, FSP

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as the lead author for standard clinical documents, including clinical study reports and study protocols.

• Compile and summarize data derived from clinical studies.

• Create complex clinical, scientific, and program-level documents such as Investigator’s Brochures (IBs), bioassay reports, Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs).

• Work collaboratively with cross-functional teams and both internal and external clients to collect information and ensure the documents are accurate and complete.

• Ensure that all documents adhere to regulatory standards, company protocols, and industry best practices.

• Contribute to the content, structure, and presentation of documents.

• Review and provide constructive feedback on documents drafted by other team members.

• Oversee timelines and deliverables for assigned projects.

• Mentor and guide junior medical writers.

• Assist the program manager as necessary.

• Keep abreast of current industry trends, guidelines, and regulatory mandates.

⛳️ Requirements

• Bachelor’s degree in a scientific field or an equivalent relevant formal academic/vocational qualification.

• An advanced degree is preferred.

• Over 5 years of prior experience providing pertinent knowledge, skills, and abilities.

• Preferably experienced in the pharmaceutical or Contract Research Organization (CRO) industry.

• Additional certifications in medical writing (such as AMWA, EMWA, or RAC) are advantageous.

• A proven history of authoring clinical regulatory documents.

• Exceptional skills in data interpretation and medical writing, encompassing grammar, editing, and proofreading abilities.

• Strong project management capabilities.

• Excellent interpersonal, problem-solving, negotiation, oral, written communication, and presentation skills.

• Comprehensive knowledge of global, regional, national, and other document development guidelines.

• Strong computer skills and proficiency in client templates.

• Good understanding of document management systems and relevant applications such as Excel and Outlook.

• Consideration may be given to meeting requirements through an equivalency of appropriate education, training, and/or directly related experience.

🏝️ Benefits

• Award-winning learning and development program.

• Competitive salary.

• Comprehensive benefits package focused on employee health and well-being.

• Flexible working culture.

• Work-life balance.

• Collaborative environment.

• Opportunities to share expertise and grow both professionally and personally.