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Regulatory Scientific Writer

4 months ago

San Diego, United States Aroga Biosciences Full time

About Us:


Aroga Biosciences is a clinical research organization that provides highly experienced regulatory writing services for biotech and pharmaceutical projects. We are a team of scientists with extensive regulatory and medical writing experience in a broad range of therapeutic areas. Our writers have in-depth experience with regulatory and publishing standards so we can ensure each document is submission ready. Our scientific backgrounds allow us to understand content at a fundamental level, which aids us in conveying messaging appropriately for its intended audience. Regulatory medical writing is our passion and contributing towards the development of novel therapeutics for ailing patients is our mission. Whether working on large submissions, protocols, or other regulatory documents, our team brings the agility and expertise to successfully and efficiently reach project goals.


Job Description:

The Regulatory Scientific Writer will work with cross-functional teams to write and edit high quality regulatory documents. For this position, there will be a focus on authoring nonclinical documents for IND submissions, including Module 2 nonclinical overview and summaries, Module 4 nonclinical study reports, Investigator’s brochures, and pre‑IND briefing packages. The ideal candidate will have a strong scientific background with a demonstrated interest in regulatory medical writing. This will be a remote position, but the ability to work onsite in our San Diego-based office once a week is highly desired.


Responsibilities:

· Author, edit, and format regulatory documents across a variety of therapeutic indications in accordance with the document template and style guide

· Ensure clarity, coherence, relevance to the audience, and accuracy of messaging during document development

· Critically review the technical content of documents to identify gaps and potential risks or challenges. Provide constructive feedback to clients.

· Conduct literature searches and prepare literature reviews

· Appropriately and clearly present data in text, tables, and figures

· Ensure documents are compliant with relevant regulatory guidelines (ie, ICH and FDA guidelines) and industry standards

· Work with internal and external project management personnel to develop document timelines and reviewer lists:

  • Align expectations regarding scope, key milestones, and deadlines
  • Identify key stakeholders or experts responsible for reviewing project materials
  • Clearly define roles, responsibilities, and expectations for each reviewer

· Document planning:

  • Prepare document outlines with the overall structure, sections, and key content elements
  • Gather and/or research relevant information, data, and source documents needed for document development
  • Track availability of source documents and manage document timelines accordingly
  • Lead document workflows by initiating authoring and review cycles, routing documents for final approval, and routing documents to QC and publishing
  • Maintain strong communication with clients and internal QC and publishing teams about deadlines, scope, and scientific content
  • Complete all assigned tasks in a timely manner and, wherever possible, ensure adherence from team members to the agreed timelines
  • Collaborate and communicate effectively with large cross-functional teams
  • Schedule, prepare for, and lead project kickoff meetings and comment resolution meetings
  • Address and resolve comments received on projects and ensure all feedback has been adequately addressed
  • Commitment to personal professional development (ie, through training, goal setting, independent research, and attending workshops/conferences)


Requirements:

· Bachelor’s degree in a medically relevant field or life science. Advanced degree (MS or PhD) is preferred.

· Experience authoring scientific documents, such as reports, protocols, and manuscripts, with clear presentation of scientific data

. Ability to critically review scientific content for clarity and accuracy with excellent attention to detail

· Strong communication skills

· Strong project management and time management skills with the ability to work to deadlines

· Flexibility/adaptability to adjust to shifting timelines and demands

Preferred Experience:

· Experience using different document templates and style guides (ie, AMA style)

· Experience using online collaborative authoring platforms (ie, Microsoft SharePoint, Veeva RIM)

· Knowledge of the drug development process and regulations

· Familiarity with IND contents, including nonclinical documents


Benefits:

· Competitive salary

· Comprehensive medical including dental and vision insurance

· Flexible work week

· Hybrid work schedule

· 401K options



Aroga Biosciences, Inc.

2023 and 2024 Top Medical Writing CRO by Life Science Review