Position Summary
The Manager, Medical Writing Operations is responsible for leading document specialist support across the Medical Writing function and for authoring and coordinating regulatory, clinical, and safety documents. This position combines medical writing expertise with advanced document production and template management capabilities, serving as a functional subject matter expert resource for writers on complex document formatting, template development, and document quality standards while ensuring deliverables are conformant with in-house style, scientifically accurate, compliant with regulatory requirements, and submission ready.
In addition to supporting the development of regulatory and clinical documents, this position serves as a subject matter expert for document formatting, template development, document quality standards, in-house style guides, and electronic document management systems. The Manager, Medical Writing Operations partners with cross-functional teams to manage and optimize document creation processes, improve efficiencies, and ensure submission-ready deliverables across all phases of product development.
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.
- Ensure scientific accuracy, consistency, and compliance of documents with company standards and applicable regulatory requirements.
- Maintain expertise in FDA, EMA, ICH, and other applicable regulatory guidance related to document preparation and submissions.
- Lead continuous improvement initiatives focused on document quality, process optimization, and operational excellence.
- Provide guidance and training to document authors and cross-functional teams regarding document standards, templates, formatting requirements, and best practices.
- Additional duties assigned as needed.
Education/Experience Requirements
- Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required. Equivalent combination of education and applicable job experience may be considered.
- Advanced degree (MS, PharmD, PhD) preferred but not 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.
- Experience authoring and/or coordinating clinical and regulatory documents supporting drug development programs and regulatory submissions.
- Demonstrated expertise in document production, template management, and advanced Microsoft Word functionality.
- Working knowledge of drug development processes and applicable global regulatory requirements.
Additional Skills/Experience/Requirements
- The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
- 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 with authoring tools and templates (eg, StartingPoint, TransCelerate) and reviewing tools (eg, PerfectIt, Litera) preferred.
- Experience with Veeva Vault, electronic document management systems, and regulatory document workflows.
- Experience with publishing tools (eg, Adobe Acrobat, Pragmatic SPL Validator) preferred.
- Expert scientific writing, editing, and document quality review skills with exceptional attention to detail.
- Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements governing clinical and regulatory documentation.
- Strong project management and organizational skills, with the ability to manage multiple priorities and competing deadlines.
- Excellent interpersonal, verbal, and written communication skills, with the ability to collaborate effectively across multidisciplinary teams.
- Demonstrated success identifying, leading, and implementing operational improvements that enhance efficiency and document quality.
- Ability to adapt to changing priorities and evolving project needs within a dynamic development environment.
- Strong professional experience in a similar role within the biotechnology, pharmaceutical, CRO, or related healthcare industry environment.
- Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
- Ability to travel up to 10% domestic and internationally.
- All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
Total Rewards Offerings
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits:Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation : Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$116,000.00 - $151,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.
