Department:
107050 Medical Writing
Location:
San Diego, USA- Remote
Position Summary:
The Senior Manager, Medical Writing is responsible for authoring, managing, and leading the development of regulatory, clinical, and safety documents, including but not limited to protocols and protocol amendments, clinical study reports (CSRs), investigator brochures (IBs), Common Technical Document (CTD) sections, briefing documents, and other submission-related documents. This position is the subject matter expert in regulatory writing and partners with cross-functional teams to provide strategic guidance and leadership ensuring documents are scientifically accurate, compliant with applicable regulatory requirements, and delivered according to project timelines. In addition, this position provides medical writing strategy and leadership across all phases of clinical development and post-marketing lifecycle management anticipating and leading process improvements and the advancement of medical writing standards and best practices.
Responsibilities:
- Author and coordinate the preparation of regulatory, clinical, and safety documents, ensuring scientific accuracy, consistency, and compliance with regulatory requirements and company standards.
- Lead cross-functional collaborations with stakeholders to develop, review, and finalize high-quality documents in support of clinical development programs and regulatory submissions.
- Manage document development timelines, review cycles, and comment resolution activities to ensure timely delivery of project milestones.
- Interpret, analyze, and summarize complex clinical and scientific data into clear, accurate, and submission-ready content.
- Ensure adherence to applicable FDA, EMA, ICH, and other relevant regulatory guidelines and industry standards.
- Proactively contribute and lead development and continuous improvements of medical writing processes, capabilities, templates, style guides, and standard operating procedures through innovation and adoption of industry best practices and drive alignment across programs.
- Develop and maintain expertise in assigned therapeutic areas and products to support scientific and regulatory communication needs.
- 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.
- 7+ 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.
- Demonstrated leadership experience authoring complex clinical and regulatory documents supporting drug development programs and regulatory submissions.
- Strong working knowledge of drug development processes and applicable global regulatory requirements.
- Exercise a high degree of independent judgment in determining approaches, priorities, and solutions for complex scientific and regulatory challenges.
Additional Skills/Experience/Requirements:
- The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork.
- Expert scientific writing, editing, and communication skills, with exceptional attention to detail and commitment to quality.
- Demonstrated experience authoring clinical, regulatory, and scientific documents within the biotechnology or pharmaceutical industry.
- Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements and guidance related to clinical development and regulatory submissions.
- Proficiency with Microsoft Office applications, Veeva platforms, and electronic document management systems.
- Strong project management and organizational skills, with the ability to manage multiple priorities and deliver high-quality work within established timelines.
- Ability to work independently while collaborating effectively with cross-functional teams and stakeholders at all levels of the organization.
- Excellent interpersonal, verbal, and written communication skills, with the ability to communicate complex scientific information to both technical and non-technical audiences.
- Demonstrated ability to adapt to changing priorities, evolving project requirements, and a dynamic development environment.
- Ability to travel up to 10% domestically 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:
$132,000.00 - $172,000.00
*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.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
