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Project Manager III, Medical Writing

Employer
Nektar Therapeutics
Location
San Francisco, CA, United States
Start date
Oct 9, 2020

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Discipline
Clinical, Medical Writing
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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.

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

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Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

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