Senior Regulatory Medical Writer for Clinical Development

Katalyst-Healthcares-; Port Reading (NJ); On-site; USD 130,000 - 200,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior regulatory medical writer in New Jersey to lead authoring of Phase 1–3 regulatory documents. You will manage complex document development, coordinates with cross-functional teams, and ensure regulatory compliance and timely delivery.

The role requires strong scientific writing, project management, and knowledge of global regulatory guidelines, with mentorship to junior writers and collaboration with clients.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent; Advanced degree preferred.
• 5+ years of relevant pharmaceutical/CRO experience.

Responsibilities

• Author regulatory documents for Phase 1–3 clinical drug development, including protocols and CSRs.
• Researches, authors, and edits IBs, IND and MAA documents.
• Reviews documents prepared by junior writers and peers.
• Provide training and mentorship on regulatory writing and processes.
• Ensure documents comply with quality processes, regulatory requirements, and client standards; develop best practices.
• Support program management including timelines, budgets, and contract modifications.
• Embrace AI and technology-enabled tools to enhance document development.
• Prioritize work to meet critical client timelines and submission deadlines.
• Deliver work within budgeted hours.

Skills

Regulatory writing

Project management

Problem solving

Negotiation

Communication

Regulatory guidelines

Regulatory submissions

Judgment/decision making

Computer skills

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

Excel

Outlook

Document management systems

Job description

Summarized Purpose:

• Provides high-quality regulatory medical and scientific writing in support of Phase 1–3 clinical development of pharmaceutical and biologic products, from planning and coordination through delivery of final documents to internal and external clients.
• Demonstrates subject matter, therapeutic area, and drug development expertise. May assist the program manager.
• Collaborates effectively with internal and external clients to support efficient document development and delivery and operational excellence.

Essential Functions:

• Serves as a primary author, providing strategic input and authoring regulatory documents supporting Phase 1–3 clinical drug development, including clinical study protocols, protocol amendments, and Clinical Study Reports (CSRs).
• Researches, authors, and/or edits complex clinical, scientific, and program-level regulatory documents, which may include Investigator's Brochures (IBs), Investigational New Drug (IND) application documents, and Marketing Authorization Application (MAA) documents.
• Reviews documents prepared by junior writers and peers.
• May provide training and mentorship to junior writers on document development, document types, regulatory requirements, processes, and therapeutic area knowledge.
• Ensures assigned documents comply with applicable quality processes, regulatory requirements, and client-specific standards. Provides input into and independently develops best practices, methods, and techniques to optimize document quality and delivery.
• May support program management activities, including developing and managing timelines, budgets, forecasts, and contract modifications, as well as identifying and addressing out-of-scope activities.
• Embraces the appropriate use of supportive AI and other technology-enabled tools to enhance the efficiency and quality of document development, in accordance with applicable processes, policies, and client requirements.
• Demonstrates flexibility, agility, and a delivery-focused mindset in a fast-paced environment, effectively prioritizing work to meet critical client timelines and regulatory submission deadlines.
• Demonstrates accountability for delivering assigned work within budgeted hours and timelines, effectively balancing quality, efficiency, and client expectations.

Education and Experience:

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience working in the pharmaceutical/CRO industry preferred.
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).