Manager, Medical Writing

Location
San Francisco, CA, United States
Posted
Oct 31, 2018
Ref
3387-515-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Essential Duties and Responsibilities:

Responsible for supporting the Clinical Development team in preparing regulatory documents such as clinical protocols and amendments, Investigator's Brochures, informed consents and INDs/IMPDs. Working knowledge of writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation. Will also contribute to the development of formats medical writing infrastructure. Remains informed of the latest professional, technological, and regulatory developments in medical writing, as well as therapeutic areas. Manages the medical writing vendors and staff. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Supports all clinical writing activities outlined in the Project Clinical Development Plans (CDPs). Writes, reviews and edits documents, offers guidance to medical writers, and takes lead in mentoring writers in the preparation of regulatory and publication documents. Ensures consistency across clinical documents and ensures adherence to regulatory publishing requirements. Organizes, conducts, and leads document production meetings and other meetings as necessary. Liaises with clinical development teams and external vendors and ensures timely production of clinical documents. Route clinical documents for review and approval. Projects Medical Writing budget, resource, and timeline requirements for CDP. Responsible for timeline management, budget and managing outside vendors on regulatory document writing projects. Develop and communicate medical writing group metrics on an ongoing basis. Responsible for developing and managing, Departmental Guidelines management system, Writing style guide and departmental templates such as, protocols, investigator's brochures, final clinical study reports, IND sections. Propose applications. Provides and manages internal and external writing activities. Responsible for developing department infrastructure such as contributing to research, acquiring a document management system, establishing style guides, and generation of templates and processes.

Minimum Qualification Requirements:

A Bachelors/Masters degree in a scientific discipline with a strong journalism background 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 6 years writing management experience is also required. An ability to create effective presentations from raw data is essential. An ability to interpret statistical and clinical data is a plus. Must have an ability to work well with others in high-pressure situations. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. An understanding of clinical research, biostatistics, and regulatory affairs is required. Must have experience writing clinical protocols, clinical study reports, and IND sections. Good computer skills are required. Working knowledge of MS word, Excel, Power point, Project, 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.