Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. Since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.
JOB SUMMARY:
The Principal Medical Writer is responsible for developing high-quality, scientifically accurate clinical and regulatory documents according to international regulatory requirements and internal document standards. This role involves interactions on a regular basis with members of internal departments. Additionally, this role will act as the liaison with outside Medical Writing Contractors.
RESPONSIBILITIES:
- Writing and integration of appropriate clinical data into protocols, investigator brochures, clinical study reports, and other clinical and regulatory documents (eg, NDA, MAA), with input from functional area experts.
- Coordinating the overall development and finalization process for assigned documents, including developing and driving timelines, hosting document review and comment resolution meetings, and obtaining approvals.
- Building and maintaining relationships with study team members, which include representatives from internal departments such as Clinical Development, Clinical Operations, Regulatory Affairs, and Biostatistics.
- Maintaining relationships with outside medical writing vendor to ensure projects are completed to our specifications.
- Representing medical writing on project teams and actively participating in interaction and providing feedback on data description, presentation, and analysis.
- Reviewing documents for clarity, accuracy, and consistency between documents.
- Developing and maintaining in-depth therapeutic and product knowledge.
- Providing quality control review of various clinical and regulatory documents.
- Advance the medical writing group via the development of writing processes and working standards.
QUALIFICATIONS:
- BS/BA required; Master’s/PhD/PharmD in life sciences preferred with 5-8 years’ experience in Medical Writing.
- Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and/or clinical data.
- Strong project management and leadership skills; ability to coordinate the efforts of team members according to timelines.
- Strong attention to detail and drive to produce high-quality documents.
- Proficient in Microsoft Project and Excel
- Excellent written and verbal communication skills
- Exceptional influencing, partnership, and collaboration skills
- Strong ability to prioritize workload
- Well-prepared, competent, and confident when interacting with senior management, health authorities, and internal and external partners
- Able to prospectively identify potential problems and to partner effectively and positively to solve issues