The Senior Medical Writer creates documents pertaining to clinical data to support product development and license applications in conjunction with corresponding project teams. Some examples of such documents include briefing documents to support meetings with regulatory agencies, clinical documents for marketing authorization applications, and responses to clinical and safety questions from regulatory authorities.
- Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
- Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.
- Support project teams by providing analyses of clinical data.
- Communicate position on resource and timeline needs for assigned documents to project team members, and keeping management informed.
- Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and management in a timely manner of any definite or potential deviations.
- Drive document strategies and messages in a collaborative way with relevant project team. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Deliver assigned documents on or before deadline, alerting project teams and management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
- Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance.
- Understand relationships and dependencies between documents and analyses produced for regulators.
- Collaborate with project team, ensuring the accuracy and quality of information presented in assigned documents.
- Identify potential areas for process improvements and possible solutions, and communicate these management.
- Master’s degree or doctorate or qualification in life sciences preferred. Alternatively, bachelor’s degree in life sciences field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas.
Experience and Ability
- BS/BA +15 years, MS/MA +13 years, PhD +10 years of relevant experience in the pharmaceutical or biotech industry with demonstrated experience leading the medical writing portion of regulatory submissions (NDAs and MAAs).
- Able to interpret complex analyses of data supporting regulatory submissions.
- Ability to serve as an authority on the interpretation of regulatory guidance and their significance in a broad range of situations.
- Expert ability to synthesize clearly written analyses of integrated patient data from single pivotal and multiple studies.
- Advanced understanding of medical concepts of the disease and extensive knowledge of current standard treatments in the disease area.
- Ability to contribute to discussions of benefit/risk assessment and regulatory impact of documents and analyses. Ability to make decisions by identifying innovative options or multiple solutions to complex problems.
- Recommends courses of action to management and senior leaders that impact the discipline, department or line.
EEO & Employment Eligibility
- TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.
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