Manager, Medical Writing

Location
San Francisco, CA, United States
Posted
Jul 12, 2018
Ref
2-1-3228-341-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

The Medical Writing Manager will work within the Clinical Pharmacology group to ensure timely delivery of Clinical Pharmacology writing projects. Responsible for researching, writing, reviewing and editing nonclinical and clinical study reports, documents for submissions to the regulatory agencies and publications. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

Manages all clinical pharmacology writing activities and takes lead in the preparation of regulatory and publication documents. Compiles, writes, reviews and edits clinical pharmacology writing deliverables such as nonclinical, clinical, and modeling and simulation reports, protocols, regulatory documents (Investigator's brochures, annual reports, briefing books, etc), and relevant IND/NDA/MAA sections. Responsible for researching, writing and editing clinical reports, summarizing data from nonclinical DMPK studies and clinical pharmacology studies for submissions to the regulatory agencies and for publication and/or presentation. Ensures all deliverables are in accordance with regulations, standards and meet FDA, ICH, GLP and GCP guidelines. Responsible for timeline management. Works with all levels of staff and management to resolve issues and update on progress. Able to work with large and small teams to achieve business goals. Responsible for developing and generating templates and processes if needed. Remains informed of the latest professional, technological, and regulatory developments in medical writing, as well as subject and therapeutic areas.

Requirements:

A Bachelors/Masters degree in a scientific discipline with knowledge of pharmacokinetics is required. Equivalent experience may be accepted. A minimum of 8 years in a pharmaceutical, biotech, or CRO medical writing position is required. A minimum of 4 years experience in writing clinical pharmacology study reports and clinical pharmacology related IND/NDA/MAA sections is also required. An ability to create effective presentations from raw data and to interpret statistical and clinical PK and PD data is essential. Must have demonstrated problem-solving abilities and be customer and results focused. Effective organizational and time management skills, and strong written and verbal communication skills are required. An understanding of drug metabolism, pharmacokinetics, clinical research, drug development, and regulatory affairs is required. Knowledge of biostatistics is desirable. Must have an ability to work well with others in high-pressure situations and to thrive under challenging deadlines. Good computer skills are required. Working knowledge of MS word, Excel, Power point.

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.