Overview
Join to apply for the Regulatory Technical Writer role at Aquestive Therapeutics.
The role is focused on leading and contributing to key regulatory documentation efforts as a Principal Regulatory Medical Writer. 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). The role will also involve leading contract medical writers and 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 (Master’s, Ph.D., or PharmD 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 statements describe the general nature and level of work and are not an exhaustive list of responsibilities, duties, and skills. The company reserves the right to make changes to the job description as necessary.
As part of the employment process, final candidates may be required to complete a drug test and background check prior to employment. The company is a drug-free workplace and maintains a drug-free workplace policy.
Aquestive provides equal employment opportunities to all colleagues and applicants 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 may provide a salary range for certain states and cities. Final salary determinations will consider factors including location, skills, experience, and education. Example base salary range: $96,000 to $150,000 USD.
Location and compensation
Location and compensation details may vary by site. Please refer to the posting for the most current information.
Employment type
Full-time
Job function
Marketing, Public Relations, and Writing/Editing
Industry
Pharmaceutical Manufacturing
Note: The original posting included additional job alerts and unrelated postings. These have been removed to focus on the core role description and requirements.