Bachelor's degree in a scientific discipline; advanced degree preferred
5+ years of experience in regulatory medical writing
Experience in the pharmaceutical or CRO industry
Qualifications in medical writing (AMWA; EMWA; RAC) are advantageous
Equivalent education and experience may be accepted
Responsibilities
Serve as primary author for regulatory documents supporting Phase 1-3 clinical development
Research, author, and edit complex clinical and regulatory documents
Review documents created by junior writers and peers
Provide training and mentorship to junior writers
Ensure compliance with quality processes and regulatory standards
Support program management activities such as timelines and budgets
Embrace AI and technology tools to enhance document development
Demonstrate accountability for work quality and client expectations
Benefits
Collaborative work environment with internal and external clients
Opportunity for mentorship and professional development
Flexibility to adapt to a fast-paced work environment
Support for innovative tools and technologies in document development
Involvement in critical regulatory submissions
Full 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.
dditional 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).
