Senior Manager, Medical Writing

Company: Travere Therapeutics
Location: San Diego
Posted on: February 22, 2021

Job Description:

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 patients.--Our 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 Senior Manager, Medical Writing is responsible for oversight and authoring (if needed) of regulatory, clinical, and safety documents, including protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), Common Technical Document (CTD) sections, and Periodic Safety Update Reports (PSURs). This position is expected to contribute directly to the drafting of high level (eg, Module 2) submission documents and be responsible for overall project management during the drafting, reviewing, and approving cycles of documents. This position will oversee the drafting of documents that are compliant with company-specific medical writing standards, are completed on-time and on-budget, and are ready for submission to global, regional, and local regulatory authorities. Additionally, this position will support projects across all phases of clinical development and post-marketing life cycle management. Essential Functions:

• Lead the overall strategy and execution of medical writing projects in support of therapeutic development programs.
• Collaborate with cross-functional team members to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents.
• Responsible for the scientific accuracy and regulatory quality assurance of developed content and deliverables.
• Responsible for implementation of medical writing review processes.
• Communicate deliverables needed, writing process, and timelines to team members.
• Contribute to the development and standardization of templates and related processes and assist in the development of templates, style guides, and SOPs for regulatory writing.
• Maintain expert knowledge of US and international regulations, requirements and guidance associated with clinical, regulatory, and safety document preparation and submissions.
• Lead and manage comment resolution meetings.
• Learn and apply knowledge of therapeutic area and product to scientific writing projects.
• Develop, maintain, and drive document finalization timelines and coordination of document review. Qualifications:--
  • Master's, PhD or PharmD in Life Science disciplines; equivalent combination of education and applicable job experience may be considered.
  • Minimum 4 years of progressively responsible medical writing experience in a biopharmaceutical/industry environment or 6+ years at a Contract Research Organization (CRO) or related environment.
  • Proficiency with Microsoft Office, and VEEVA platforms and use of Starting Point electronic document templates.
  • Time management and project management skills are essential.
  • Knowledge of FDA, EMA, ICH, and other applicable guidelines and regulations.--
  • Experience or background in working within the pharmaceutical industry, awareness of compliance issues and guidelines around medical education and publications.
  • Ability to manage various projects, solve problems, deliver on commitments and work with multidisciplinary teams.
  • Independent, self-starting individual with a demonstrated ability to thrive in smaller company culture and environment is required.
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
  • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer Posted 30+ Days Ago Full time R-100079 About Us Travere Therapeutics is a biopharmaceutical company with a global team dedicated to working with the rare disease community to identify, develop and deliver life-changing therapies. The Company's development efforts are led by sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN) - rare kidney disorders that often lead to end-stage kidney disease. The company is also advancing TVT-058 for the treatment of classical homocystinuria, a genetic metabolic disorder that can cause life-threatening thrombotic events. Travere Therapeutics' early research efforts include partnering with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. The Company also delivers four FDA-approved therapies, Chenodal--, Cholbam--, Thiola-- and Thiola EC--, and is committed to ensuring broad access, educational and financial support for patients. For more information, visit travere.com.

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