Principal Regulatory Medical Writer

Job Summary:

We are seeking a highly skilled Principal Regulatory Medical Writer to lead and contribute to key regulatory documentation efforts. The ideal candidate will have 4-8 years of experience in regulatory medical writing and a strong background in drafting essential regulatory documents, including Investigator’s Brochures (IBs), briefing books, responses to regulatory inquiries, and clinical study reports (CSRs). Additionally, this role will be responsible for leading contract medical writers, ensuring consistency, quality, and alignment with AMA and regulatory requirements.

Responsibilities:

• Author and edit high-quality regulatory documents, including IBs, briefing books, CSRs, and responses to regulatory authorities.

• Lead and mentor contract medical writers, providing guidance, oversight, and quality assurance in regulatory document development.

• Ensure regulatory compliance by following industry standards, guidelines, and best practices.

• Collaborate cross-functionally with clinical, regulatory, and scientific teams to ensure clarity and accuracy in submissions.

• Manage timelines and oversee document preparation schedules to meet regulatory submission deadlines.

• Implement strategic input provided by the regulatory team to ensure alignment with strategy within and across content of documents. 

• Review and QC documents for consistency, scientific accuracy, and regulatory alignment.

Qualifications:

• Bachelor’s degree in life sciences (a higher degree such as Master’s, Ph.D., or PharmD is preferred).

• 4-8 years of experience in regulatory and/or clinical medical writing within the pharmaceutical or biotech industry.

• Strong leadership skills with prior experience leading medical writers.

• Deep knowledge of AMA style guide requirements.

• Excellent writing and editing skills with the ability to convey complex scientific information clearly and concisely.

• Detail-oriented with strong organizational skills to manage multiple projects simultaneously.

• Proficiency in Microsoft Word and other document management tools (StartingPoint templates, Veeva RIM, etc).

• Expertise in writing and managing complex regulatory submission documents for clinical development programs.

• Strong understanding of medical terminology and clinical trial methodology.

This role is ideal for an experienced regulatory medical writer looking to take on leadership responsibilities while driving key regulatory submissions. 

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. 

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.  Please Note:  Aquestive is a drug-free workplace and has a drug free workplace policy in place. 

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.  Expected Base salary range: $96,000 to $150,000 USD