We have a current opportunity for a Senior Manager, Medical Writing on a permanent basis. The position will be based in Menlo Park. For further information about this position please apply.
Senior Manager, Medical Writing
On-site - Menlo Park, CA
Summary:
A leading biotechnology company responsible for the drug development that modulates the effects of cortisol which are seen in a variety of endocrine, metabolic, oncological, and psychiatric diseases. Currently working in phases 2-3 in their clinical trial pipeline which deals with a variety of therapeutic areas. They are currently working on 17 ongoing trials. As a medical writer, you will be responsible for the preparation of CSR's and protocols as well as proficiency in ICH and FDA guidelines. The position will collaborate with colleagues to write high-quality, strategically aligned medical writing deliverables that support the requirements of regulatory clinical development. Must ensure accuracy, completeness and compliance with US and ex-US regulatory requirements. Are you motivated and passionate about the life science industry? If yes, please reach out to learn more.
Responsibilities:
- Author, co-author, critically edit, and format clinical/regulatory documents including NDA's, CSR's, protocols, protocol amendments, investigator's brochures, administrative letters, and other regulatory submissions.
- Proficient in ICH and FDA guidelines.
- Lead meetings and document review.
- Develop and manage medical writing timelines.
- Oversee vendors and contractors (as necessary).
- Develop/refine medical writing processes, SOP's, work instructions, templates, style/content guides, and document quality control.
- Maintain subject area expertise.
- Ability to manage a variety of projects independently.
- Lead without formal authority
Qualifications:
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred.
- Knowledge of endocrinology, oncology, neurology and/or metabolic disease areas preferred.
- 5+ years of regulatory medical writing experience in the pharmaceutical industry.
- Experience writing clinical study protocols, clinical study reports, investigator's brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications.
- Success in writing complex regulatory/clinical writing projects across multiple therapeutic areas.
- Understand drug development process.
- Familiarity with US and European regulatory requirements and guidelines.
- Ability to analyze critically and synthesize complex scientific information from a range of disciplines and therapeutic areas.
- Proficiency in MS Office applications, Adobe Acrobat, templates, and electronic document management systems.
Benefits:
- Medical, Dental, and Vision
- Life Insurance
- 401(k)
- PTO, sick and flex-time policies
Please reach out to Valentin Tenbrook for more information!
857-453-4071
