Manager, Medical Writing Operations

Department:

Location:

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare work is rewarding both professionally and personally because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative diverse fast-paced environment and share in our mission to identify develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients courage community and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

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:

• Bachelors 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 Traveres 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:

*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 candidates experience education skills and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

Travere Therapeutics Inc. is an EEO/AA/Veteran/Disability Employer.

If you require a reasonable accommodation to complete the application or interview process please contact us by sending an email to . Please note that this email address is to be used exclusively to request an accommodation with the online application interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.