Project Manager III, Medical Writing

Location
San Francisco, CA, United States
Posted
Oct 09, 2020
Ref
5188-750-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Project Manager III, Medical Writing to join their Medical Affairs team.

The Project Manager III will assist Clinical Development with preparation of regulatory documents such as clinical protocols, clinical study reports, and Investigator's Brochures across all programs. Liaises with cross functional teams and external vendors to ensure timely production of documents. Organizes, conducts, and leads document production meetings and other meetings as necessary. Provides input on agendas and maintains meeting minutes. Ensures adherence to Medical Writing processes. Routes clinical documents for review and approval. Assists with distribution and control of clinical and regulatory documents. Maintains all aspects of documentation. Coordinates QC review and archive QC documents. Ensures consistency across clinical documents and adherence to regulatory publishing requirements. Helps to ensure compliance with regulatory and Good Clinical Practices (GCP) requirements. Participates in implementation of department infrastructure such as, document management system, and maintenance of templates and medical writing processes.

A minimum of a Bachelors degree in a scientific discipline or business or related discipline is required. Additionally, a minimum of 5 years project management experience in the development of pharmaceutical, medical products, or other related industry experience is required. Certification in Project Management or demonstrated continuing education in Project Management is preferred. Prior experience in managing interdisciplinary or cross functional projects is required. An understanding of FDA regulatory (GxP) processes is highly desired. A working knowledge of basic financial accounting is required. Proficient computer skills and good working knowledge of MS Word, Excel, PowerPoint, and Project are required. Must be able to demonstrate strong analytical and problem solving capabilities. Excellent oral and written communication skills are required. Must possess and demonstrate strong leadership, influencing and organizational skills.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.