Manager, Medical Writing Operations
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Manager of Medical Writing Operations at Travere Therapeutics, overseeing document quality and regulatory compliance. Leading document creation processes to support drug development for rare disease treatments.
Responsibilities:
- Serve as a subject matter expert for Microsoft Word, document formatting, style management, templates, and document production best practices
- Perform advanced document formatting and publishing activities, including management of complex tables, figures, references, cross-references, automated numbering, table of contents generation, and document quality control
- Manage document development timelines, review cycles, and comment resolution activities to ensure high-quality deliverables are completed on schedule
- Develop, maintain, and improve standardized document templates, style guides, macros, and formatting tools to support efficient document development and regulatory submissions
- Partner with Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, and other functions to ensure documents are submission-ready and comply with regulatory publishing requirements
- Author and coordinate the preparation of clinical, regulatory, and safety documents, including protocols, protocol amendments, clinical study reports (CSRs), investigator brochures (IBs), CTD components, and other submission-related documents.
Requirements:
- Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required
- 6+ years of relevant experience in medical writing, regulatory writing, document management, publishing, or medical writing operations within the biotechnology, pharmaceutical, CRO, or related healthcare industry environment
- Advanced proficiency in Microsoft Word, including styles, templates, section management, automated numbering, cross-references, tables of contents, document comparison tools, and large-document management
- Experience authoring and/or coordinating clinical and regulatory documents supporting drug development programs and regulatory submissions.
- Working knowledge of drug development processes and applicable global regulatory requirements.
Benefits:
- premium health
- financial
- work-life
- well-being offerings for eligible employees and dependents
- wellness and employee support programs
- life insurance
- disability
- retirement plans with employer match
- generous paid time off
Similar Jobs
Hair & Beauty Content Writer
Hair & Beauty Content Writer creating SEO-focused content for a beauty brand incubator. Responsible for producing high-quality, research-backed content aligned with brand goals.
Senior LinkedIn Writer
Senior LinkedIn Writer for a personal-branding agency, creating high-quality LinkedIn content and thought leadership materials. Involves engaging with senior executives and collaborating with agency leadership.
Quote and Proposal Writer – Environment Testing
Quote and Proposal Writer supporting Environmental Business Development at Eurofins. Creating proposals based on client needs and ensuring compliance with lab specifications.
Autor, Lektorat/Korrektorat, Fortbildungsinhalte, Pflegekinderhilfe / Vollzeitpflege
Fachautor*in für Fortbildungsinhalte im Bereich Pflegekinderhilfe und Vollzeitpflege für eine E-Learning-Plattform. Unterstützung bei der Erstellung und Entwicklung von Bildungsinhalten und Curricula.
Strategic Proposal Writer
Strategic Proposal Writer at Parexel driving proposal success and managing contract development. Collaborate with leaders to create compelling proposals in a leading Clinical Research Organization.
Product Writer I
Create and maintain clear end-user content for NGP VAN products. Collaborate with product, support, and enablement teams on documentation accuracy.
Medical Writing Operations Manager
Medical Writing Operations Manager at Pfizer guiding vendors and project teams on medical writing standards and leveraging AI tools to enhance operational efficiency.
Grant Writer
Contract Grant Writer developing compelling proposals for Canadian R&D funding. Seeking adaptable writers for diverse projects with varying experience levels.
Freelance Writer, Consultant – Your Side Hustle
Consultant for individuals with experience using various gig apps like Upwork and Care.com. Focusing on short-term, no-pressure consulting work.
Content Creator – eLearning Professional
Content creator for e-learning at ADR Formación, responsible for developing and tutoring online courses. Collaborate with a community of professionals in the educational sector.
Blog and Article Writer
Blog & Article Writer at NoGigiddy producing articles on side hustles and personal finance. Focus on research, SEO optimization, and engaging writing style for a growing platform.
Blog & Article Writer
Blog & Article Writer creating well-researched articles for NoGigiddy. Focused on gig economy, side hustles, and personal finance with an emphasis on SEO optimization.
Blog & Article Writer
Blog & Article Writer at NoGigiddy producing informative articles on gig economy, side hustles, and personal finance topics. Writing content to build trust and attract traffic to the platform.
Train Travel Writer
Freelance travel writer for TheTravel, a rapidly growing online travel publication. Sharing unique travel stories and experiences about destinations, culture, and trends.
National Park Writer
Freelance travel writer for TheTravel, an online travel publication inspiring exploration. Responsible for researching and writing captivating travel articles on various destinations and cultures.
Cruise Writer
Freelance travel writer focusing on original travel articles for TheTravel. Contributing to a publication that inspires exploration with a wide audience reach.
Air Travel Writer
Freelance travel writer for TheTravel, dedicated to inspiring exploration through captivating stories about travel destinations. Join the team to produce unique, high-quality travel content.
Proposal Writer
Proposal Writer analyzing customer requests for healthcare solutions and collaborating with teams for innovative responses. Demonstrating business value and meeting strategic goals within the firm.
Senior Communications Writer
Senior Communications Writer translating complex total rewards business plans into clear messaging for a leading tech company. Partnering closely with program managers and creatives for cohesive communication strategies.
Bid Writer
Bid Writer creating persuasive proposals and tender documents for NEC Software Solutions. Collaborating with teams to articulate solutions while driving new business and growth.