job summary: Manager, Medical Writing
Possibility of remote work
location: San Francisco, California
job type: Contract
salary: $61.74 - 72.64 per hour
work hours: 9 to 5
responsibilities: Job 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.
- 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.
- Provides input into 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.
qualifications: Education & Qualifications
- 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.
skills: Editing, IND, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project, GCP (Good Clinical Practice), Safety Narrative, QC Review
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.