This listing was posted on ApplicantList.
Scientific Writer - OBPV
Location:
Silver Spring, MD
Description:
Kaiva Tech, LLC is seeking a Scientific Writer in the DC Metro Area . Clearance : Ability to obtain a Public Trust. Job Summary : The Scientific Writer will support the Food and Drug Administration's ( FDA) Center for Biologics and Research (CBER) for the Office of Biostatistics and Pharmacovigilance (OBPV) staff prepare post-market memoranda, edit and format reviews memos, manuscripts, and policy documents as well as attend and summarize meetings with FDA stakeholders as needed. The position requires organization, attention to detail, reliability, consistency, and interaction with FDA stakeholders across several Offices and Divisions. Supervisory Responsibilities : None. Essential Duties and Responsibilities : As a Scientific Writer your responsibilities will include, but are not limited to the following: Working with FDA stakeholders on complex scientific documents by editing for readability and flow, including study protocols, white papers, presentations, and manuscripts for submission to peer-reviewed journals. Working with a team of editors and writers during revisions to manage document control, while editing and formatting for consistency and one voice. Assisting in developing visual communication aids including graphs, figures, and infographics. Copyediting nearly completed manuscripts for grammar, punctuation, style, and internal consistency. Performing literature searches to assist with document editing and revision. Performing routine quality checks on the work of other medical writers/editors. Managing SharePoint site organization and updates. Working collaboratively with colleagues to share lessons learned. Helping customers identify ineffective or inefficient process areas and recommend improvements. Identifying areas where Health Science practitioners can help current and future customers. Checking documents for 508 Compliance. Working with FDA stakeholders on requirement gathering, project scope, risks, and deliverables. Assisting with overall project support. Required Experience and Skills : At least 2 years of experience of copyediting experience and familiarity with a style guide (e.g., AP, Chicago, or AMA) Ability to take meeting minutes and synthesize discussion points Excellent organizational, time management, and communication skills Demonstrated experience working independently as well as in a team environment Experience in synthesizing and disseminating information regarding complex issues, decisions, or policies Experience with Microsoft Office and reference software Intermediate experience and/or certification in Microsoft Word with willingness to learn new features Preferred Experience and Skills : At least 3 years of experience in pharmacoepidemiology studies using large health claims databases or electronic health records systems Experience editing guidelines or other policy documents for the federal government Familiarity with SharePoint, EndNote, and Visual Basic Familiarity with 508 compliance Familiarity with FDA regulation of drugs and biological products and EUA and BLA review processes Ability to understand and follow scientific discussion on drugs, side effects, placebo effects, adverse events, and labeling Education : Master's or PhD in in epidemiology or biostatistics Candidates with Master's or PhD in infectious disease and public health can also apply Certificates, Licenses and Registrations : None. The above statements are intended to describe the general nature and level of work being performed by the individual(s) assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. Kaiva Tech, LLC reserves the right to modify, add, or remove duties and to assign other duties as necessary. In addition, where applicable and available, reasonable accommodation(s) may be made to enable individuals with disabilities to perform essential functions of this position. Kaiva Tech is a proud Equal Opportunity Employer! All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, genetics, disability or veteran status. Job Posted by ApplicantPro
Company:
Kaiva Tech
Posted:
January 25 on ApplicantList
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to ApplicantList
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Scientific Writer - OBPV
Scientific Writer - OBPV is a Media, Journalism & Newspaper Jobs Writer Job at Kaiva Tech located in Silver Spring MD. Find other listings like Scientific Writer - OBPV by searching Oodle for Media, Journalism & Newspaper Jobs Writer Jobs.
Scientific Writer - OBPV is a Media, Journalism & Newspaper Jobs Writer Job at Kaiva Tech located in Silver Spring MD. Find other listings like Scientific Writer - OBPV by searching Oodle for Media, Journalism & Newspaper Jobs Writer Jobs.