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Remote Regulatory Writing Jobs in Oregon (NOW HIRING)

Treliant LLC

Regulatory Compliance Consultant

$75 - $150/hr

These roles are project-based and 100% remote. Responsibilities While the scope of each project may ... Excellent written and verbal communication skills to include client report writing and presentation.

ZEISS

Senior Advisor, Regulatory and Clinical Affairs

OR · Remote

$183K - $228K/yr

This position is a remote role. What's the role? The Senior Advisor,Regulatory and Clinical Affairs ... Must have excellent communication skills, both written and oral, and must be computer literate. * A ...

Pantheon Systems, Inc

Technical Writer

OR · Remote

$85K - $119K/yr

Pantheon is a vibrant, remote-forward team of experts who care deeply about their craft and results ... Quality technical writing is the foundation on which the Developer Relations group (of which this ...

360training

Food and Beverage Senior Course Writer

Over the years, we have continued to grow our expansive library of regulatory-approved training ... This is a remote position and we are looking to hire in the following states: AZ, FL, GA, NJ, PA ...

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Remote Regulatory Writing information

What are the key skills and qualifications needed to thrive as a Remote Regulatory Writer, and why are they important?

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.
What are popular job titles related to Remote Regulatory Writing jobs in Oregon? For Remote Regulatory Writing jobs in Oregon, the most frequently searched job titles are:
What job categories do people searching Remote Regulatory Writing jobs in Oregon look for? The top searched job categories for Remote Regulatory Writing jobs in Oregon are:
What cities in Oregon are hiring for Remote Regulatory Writing jobs? Cities in Oregon with the most Remote Regulatory Writing job openings:
Remote Regulatory Writing jobs near you
Associate Director, Medical Writing (Clinical and Regulatory)

Associate Director, Medical Writing (Clinical and Regulatory)

Ultragenyx Pharmaceutical

OR • Remote

Other

Posted 7 days ago

Job description

Position Summary:

ultrafocused - Work together to fearlessly uncover new possibilities

The Associate Director, Medical Writing will be responsible for writing and coordinating the writing of various clinical and regulatory documents, including protocols/amendments, investigator brochures, clinical study reports, and NDA/BLA submission documents. The Associate Director, Medical Writing will work closely with cross-functional teams to manage the preparation of written clinical and regulatory documents, ensuring that they are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The Associate Director will be seen as a key SME for medical writing, providing leadership across global teams.

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Development and implementation of cross-functional input for clinical and regulatory documents including the drafting, editing, reviewing, and ensuring quality of key messages, protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, response documents, and briefing books

2. Ensures smooth, effective, and timely document management from start (template) to finish (approval), which may include: first-draft authoring, literature and reference retrieval, editing, efficient comment resolution, and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving) with high quality

3. Actively supports cross-functional project teams as the Clinical Regulatory Writing representative, providing input to ensure timely and accurate deliverables and negotiating timelines as necessary

4. Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.) and partners with Clinical Trial and Transparency colleges.

5. Develops effective collaborative relationships with other key functional stakeholders

6. Participates in department initiatives with other Clinical Regulatory Writing members to formulate writing strategies and standards to be implemented and takes responsibility for execution.

7. Distills large amounts of clinical and scientific data into essential elements for tabular and graphical display

8. Ensures that all documents are written in compliance with relevant clinical and regulatory requirements including continual knowledge of ICH and Health Authority guidance.

Requirements:

1. BS, MS, or doctorate in a scientific or medical field

2. Six+ years in the biotechnology/pharmaceutical industry

3. Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus.

4. Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support

5. Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects

6. Proven ability to develop and implement medical writing processes and standards

7. Exceptional oral and written communication skills

8. Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues

9. Flexible; adapts work style to meet organization needs

10. Strong organizational abilities and experience in a multitasking environment

11. Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals

12. Dedication to quality and reliability

13. Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus)

14. Ability to build and maintain effective partnerships, both internally and externally

15. Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels

16. Rare disease experience and/or gene therapy experience a plus

17. Ability and willingness to travel several times a year

#LI-CS1 #LI-Remote

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