Manager - Associate Director, Medical Writing
NGM Biopharmaceuticals, Inc. is a private biotech company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to form a company where innovation and cutting edge science has provided the foundation for a robust drug discovery engine. To date, NGM Bio has generated a pipeline of six drug candidates in various stages of development, including NGM282 that recently demonstrated proof-of-concept in a Phase 2 study in non-alcoholic steatohepatitis (NASH). In 2015, we entered into a broad, strategic collaboration with Merck that will provide us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.
The position will report to the Regulatory lead and will be the medical writing lead for regulatory and other key documents. This position requires you to be able to write independently and work effectively with cross functional colleagues to develop and complete documents.
- Lead, draft and oversee the completion of regulatory submission and other key documents (e.g., clinical protocols, investigator brochures, clinical study reports, eCTD/IND clinical and nonclinical summaries, DSURs, orphan annual reports) and Module 1 documents
- Collaborate with the regulatory team members to support the timely completion of all regulatory documents
- Support the writing and completion of responses to regulatory agency questions and comments
- Analyze clinical and nonclinical data for the various projects and perform literature-based research to support writing activities
- Ensure effective document management from initial draft to final signature, including management of various processes (e.g., oversight of the review process, addressing comments with functional leads, lead resolution meetings and document archiving)
- Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
- MS, or doctorate in a scientific or medical field
- 8+ years in the biotechnology/pharmaceutical industry
- Prior experience in metabolic/liver disease/ophthalmology or oncology preferred
- Demonstrated experience as a primary author, writing and editing regulatory scientific documents and worked on at least one eCTD/IND/BLA submission
- Effective in building partnerships and maintaining relationships
- Skilled at analyses of literature and data analyses and worked with diverse group of clinical and nonclinical scientists
- Strong document management skills with ability to be effective with minimal supervision
- Ability to manage multiple projects in a fast-paced environment with changing priorities and demonstrated leadership ability to drive results that are needed to get the projects completed
- Exceptional oral and written communication skills
- Excellent computer skills (Microsoft Office Suite; Project experience a plus)
- Candidate may have the option to work remotely
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.
Interested applicants should click "Apply Now"
JOB LOCATION South San Francisco, California, United States
POSITION TYPE Full-Time/Regular