Senior Medical Writer
Katalyst Healthcares and Life Sciences
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.
- 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.
- 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.
- 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).
Vacancy posted 2 days ago
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