Principal Medical Writer, Regulatory & Scientific Writing

Job Description

Principal Medical Writer, Regulatory & Scientific Writing

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Location: Remote or Hybrid in San Diego

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Employment Type: Full time

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Reports To: President & Founder

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About Aroga

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Aroga Biosciences is a full-service CRO providing expert medical writing, regulatory writing, quality control, regulatory operations, and submission management services to biopharmaceutical companies.

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We serve as a strategic extension of our clients’ teams, helping them navigate complex regulatory and clinical milestones with precision, agility, and deep expertise.

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About the Role

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Aroga Biosciences is seeking an experienced Principal Medical Writer, Regulatory & Scientific Writing to join our team and play a critical role in helping biopharmaceutical clients advance their programs toward important clinical and regulatory milestones.

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This is an opportunity for an accomplished scientific and regulatory writer who understands that great medical writing is more than putting words on a page. You will translate complex clinical and scientific information into clear, accurate, well-structured documents that meet regulatory and submission requirements and support successful drug development programs.

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In this role, you will independently author, co-author, critically review, and format a broad range of regulatory and scientific documents, including complex submissions. You will serve as a lead on assigned projects, advise clients and cross-functional teams on content, organization, format, style, and regulatory expectations, and help ensure that projects move forward efficiently and to a high standard of quality.

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You will also bring leadership beyond individual documents—supporting medical writing processes, quality control, SOPs and work instructions, maintaining subject-matter expertise, and helping identify opportunities to use technology and improved processes to make our work more efficient, while mentoring other team members.

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Qualifications

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We're looking for an accomplished medical writer who combines exceptional scientific and regulatory writing ability, sound scientific judgment, regulatory knowledge, and the ability to work independently and collaboratively with clients and cross-functional teams.

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• Bachelor's degree in a scientific discipline required; Master's, PhD, or PharmD preferred.
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• A minimum of 5 or more years of regulatory writing and submission experience.
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• Advanced knowledge of clinical and regulatory documents and scientific publication practices.
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• In-depth knowledge of relevant regulatory guidance and a strong foundation in clinical research.
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• Demonstrated ability to independently write and critically review complex regulatory documents.
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• Strong understanding of the drug development process and regulatory environment.
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• Advanced knowledge of applicable standards and guidelines, including GCP, ICH, ICMJE, and CONSORT.
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• Demonstrated ability to interpret, analyze, and effectively present scientific and clinical trial data, with a strong understanding of statistical analyses.
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• Excellent scientific, medical, and regulatory writing and editing skills.
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• Excellent interpersonal, communication, and collaboration skills.
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• Ability to build strong working relationships and effectively collaborate with cross-functional teams.
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• Ability to manage multiple projects simultaneously and work effectively in a dynamic, deadline-driven environment.
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• Expert proficiency with Microsoft Word, PowerPoint, and Excel.
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• Technologically savvy, with an interest in and ability to support implementation of software and technology solutions that improve medical writing processes.
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• Ability to travel periodically for client meetings, conferences, training, or other business needs.
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The anticipated base salary range for this position is $128,000–$160,000 annually. Actual compensation and position/title will be determined based on experience, qualifications, internal equity, geography and business needs. This role is also eligible for an annual incentive bonus and a comprehensive benefits package.

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Why Aroga?

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At Aroga, you won't simply manage a team—you'll help shape the quality and impact of the work we deliver to our clients.

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Our work sits at the intersection of science, medicine, regulatory strategy, and exceptional writing. As a Principal Medical Writer, Regulatory & Scientific Writing, you'll have the opportunity to influence important drug development programs while developing talented medical writers and strengthening the capabilities of a growing organization.

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If you are an experienced regulatory medical writer who is ready to lead people, influence projects, partner with clients, and help build a high-performing medical writing function, we'd love to hear from you.

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Ready to Make an Impact?

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Join Aroga Biosciences and help turn complex science into clear, compelling evidence that moves drug development forward.

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Apply today.

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This job description reflects the primary responsibilities and qualifications of the position and is not intended to be an exhaustive list of all duties, responsibilities, or requirements.