Project Manager III
- Employer
- Nektar Therapeutics
- Location
- San Francisco, CA, United States
- Start date
- Apr 12, 2019
View more
- Discipline
- Clinical, Clinical Research, Medical Writing
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Assists Clinical Development with preparation of regulatory documents such as clinical protocols, clinical study reports, and Investigator's Brochures across all programs.
Assists Clinical Development with preparation of regulatory documents such as clinical protocols, clinical study reports, and Investigator's Brochures across all programs. Coordinates the protocol, clinical study report and Investigator's Brochure writing efforts. Interacts with medical writing vendors and cross- functional teams and participates in project team meetings. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Develops and maintains clinical document project timelines. 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 archives 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. Other duties as assigned.
A Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 4 years experience in the a pharmaceutical, biotech, medical products industry or CRO is required. Strong organizational and project management skills are required. Must have demonstrated problem solving abilities. Strong written and verbal communication skills are required. Must be willing to work as part of a team. Must have demonstrated good interpersonal skills. Good computer skills are required. PMP certification is a plus. Working knowledge of MS word, Excel, Power point, and Outlook is a plus.
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
- Website
- http://www.nektar.com/
- Phone
- 415-482-5300
- Location
-
455 Mission Bay Blvd South
San Francisco
California
94158
United States
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