Senior Manager, Medical Writing
Company: Travere Therapeutics
Location: San Diego
Posted on: February 22, 2021
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
- 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,
- Responsible for the scientific accuracy and regulatory quality
assurance of developed content and deliverables.
- Responsible for implementation of medical writing review
- 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
- 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
- Proficiency with Microsoft Office, and VEEVA platforms and use
of Starting Point electronic document templates.
- Time management and project management skills are
- Knowledge of FDA, EMA, ICH, and other applicable guidelines and
- 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
- 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
Keywords: Travere Therapeutics, San Diego , Senior Manager, Medical Writing, Advertising , San Diego, California
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