Regulatory Writers Position Available In Wake, North Carolina

Regulatory Writers 3.4 3.4 out of 5 stars Raleigh, NC •

Remote Job Title:

Regulatory Writer (Mid-Level)

Location:

Remote Department:

Regulatory Affairs /

Medical Writing Job Type:

C2C / 1099

Reports to: Scientific Director Regulatory Medical Writer –

NDA Submission Support Location:

Remote | Contract (Immediate Need)

Pay Range:

$60 – $85

Position Overview:

We are supporting a potential new client with an urgent need for regulatory writing support in preparation for an NDA submission to the FDA . We are seeking a skilled Regulatory Medical Writer with direct experience preparing submission-ready documents for NDA filings. This includes authoring and editing SOPs, study protocols, investigator brochures, regulatory response documents, and Module 2 summaries. Familiarity with FDA expectations and a strong understanding of ICH and GDPs guidelines is required. This role is ideal for experienced regulatory medical writers who can step in quickly and contribute to the development of SOPs, protocols, and regulatory documents. We are seeking a detail-oriented and experienced Regulatory Writer to join our Regulatory Affairs team. In this mid-level role, you will be responsible for preparing, reviewing, and editing high-quality regulatory documents that support the development and approval of pharmaceutical products.

Key Responsibilities:

Prepare and author regulatory documents such as Clinical Study Reports (CSRs), Investigator Brochures (IBs), Protocols, INDs, NDAs, MAAs, and Briefing Documents in accordance with ICH and regional regulatory requirements. Collaborate with subject matter experts to gather and interpret scientific data. Ensure consistency, clarity, and accuracy in content and language, while maintaining compliance with relevant regulations and guidelines. Ensure all content meets regulatory and internal quality standards. Participate in planning and content development meetings to define document strategy, timelines, and deliverables. Conduct peer reviews and QC checks of documents prepared by team members. Track document development processes, timelines, and version control using document management systems (e.g., Veeva, Documentum). Support responses to regulatory authority questions by preparing high-quality written materials. Collaborate closely with cross-functional teams including client’s Clinical, Safety, CMC, and Regulatory Affairs to ensure the timely and compliant delivery of submission-ready documentation. Understand the sense of urgency required working within the NDA submission guidelines and impact on downstream processes with delays in meeting deadlines.

Qualifications:

Education & Experience:

Bachelor’s or advanced degree in a Life Sciences field or a related field. 3-5 years of regulatory writing experience in the pharmaceutical, biotechnology, or medical device industry. Proven track record in authoring and managing regulatory documents across multiple phases of development. Medical Writing experience and expert level understanding of pharmaceutical clinical study protocols.

Skills & Competencies:

In-depth understanding of US regulatory requirements and guidelines. Global experience is a plus, but not required. Excellent written and verbal communication skills. Strong organizational skills and attention to detail. Ability to interpret complex clinical and scientific data. Proficiency in Microsoft Office and document management systems. Ability to manage multiple projects. Must be able to work W2. Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. Established in 1979 we lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs. But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!) Apply today to join our family and Make Your Mark! About Alphanumeric Systems Inc.: Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.

But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!