Scientific Writer

Kaiva Tech, LLC is seeking a Scientific Writer in the DC Metro Area.

Clearance: Ability to obtain a Public Trust

Workplace Type: Currently 100% remote due to COVID. Please be aware that the workplace type allowed is approved by the client and is subject to change dependent on client needs and expectations.

Summary Overview:

The Scientific Writer will support scientists at the US Food and Drug Administration (FDA) who regulate gene therapy, cell therapy, tissue transplantation and other biological treatments for human diseases. The Scientific Writer will work closely with FDA scientists to write and edit regulatory documents, manuscripts for submission to medical journals, and materials for presentation at scientific conferences. The position requires demonstrated skill in medical writing/editing and the ability to understand and interpret data from clinical trials.

Supervisory Responsibilities:

• None.

Essential Duties and Responsibilities:

As a Scientific Writer your responsibilities will include, but are not limited to the following:

• Working with teams of FDA scientists to write and edit regulatory documents such as product reviews and policy guidelines.
• Reviewing and summarizing literature to draft background sections for product reviews; summarizing clinical trial designs using details from clinical study reports.
• Editing product review documents to correct tone, flow, verb tense, and style; making decisions regarding style and consistency of terms; identifying factual errors and misstatements; suggesting revisions for clarity and brevity.
• Drafting original manuscripts from outlines provided by FDA scientists; incorporating comments from multiple authors into successive drafts; assisting authors with submission to journals and addressing comments from peer review.
• Editing manuscripts written by FDA scientists, critically reviewing for completeness, balance, and fitness of conclusions.
• Formatting data tables; creating and populating data tables using data derived from regulatory submissions to the FDA.
• Inserting and managing citations and references; performing routine formatting tasks such applying Microsoft Word styles and field-coded captions to ensure the functionality of automated tables of contents and lists of tables and figures.
• Using records of communication between the FDA and sponsors of biological products such as gene therapies, developing and maintaining a database of answers to questions most frequently asked by sponsors, organizing them by topic area (e.g., trial design, blinding, randomization).
• Communicating efficiently and effectively with FDA scientists regarding requirements and timelines for writing/editing projects.
• Performing routine quality checks on work performed by other medical editors.
• Providing support for the onboarding and training of new medical editors as needed.

Required Experience and Skills:

• Ability to understand and follow scientific discussion on clinical trials, adverse events, treatment efficacy, and product labeling.
• At least 2 years of experience as a medical writer/editor.
• Adept with English grammar, spelling, punctuation.
• Familiar with Microsoft Word including track changes.
• Attention to detail (e.g., ability to recognize an extra space between words or in the cell of a data table).
• Willing to perform mundane formatting tasks.

Desired Experience and Skills:

• Academic or professional experience with biologics such as vaccines, blood products, gene therapy, stem cells, or tissue transplantation.
• Author of medical journal publications.
• Familiar with FDA regulatory processes.
• Familiar with AMA style.
• Familiar with Section 508 compliance.
• Savvy with Microsoft Word features such as styles, captioning, and cross-referencing.
• Experience with SharePoint, EndNote, Adobe Acrobat, Excel, PowerPoint.

Education:

• Bachelor's Degree in a Scientific or Health Field required.
• Advanced Degree such as MPH, PharmD, or PHD preferred.

Certificates, Licenses and Registrations:

• None.

Physical Requirements:

• Ability to sit and work with a computer for prolonged periods of time.

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 Corporation 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 Corporation 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, disability or veteran status.