Regulatory Medical Writer II

LOCATION: Lexington, MA/moving to Waltham, MA Q1 2027 (on-site/hybrid)

POSITION SUMMARY

The Regulatory Medical Writer II is an entry-level professional responsible for drafting, editing, and formatting early-stage regulatory submission documents for both pharmaceutical drugs (INDs) and medical devices (510k applications). Operating under direct supervision, this role focuses on translating complex scientific, preclinical data into clear, compliant, and submission-ready documentation. The Regulatory Medical Writer II works closely with cross-functional teams—including Regulatory Affairs, Sponsors, and Operations to ensure all documents strictly adhere to company style guides, FDA regulations, and international standards (such as ICH guidelines ). In addition to regulatory writing, the Regulatory Medical Writer II will also assist in the coordination, assembly, writing, editing and quality control of study/data reports, and/or protocols, which accurately reflect the study data and fulfill all protocol and regulatory requirements. Additionally, involved in the development of report and data structure and presentation formats with preparation of text tables and/or associated graphs for reports and/or presentations. Assist in guiding others on specific regulatory documents and document preparation strategies.

Salary Range: $62,000 - $90,000. (Please note, salaries vary within the range based on factors including, but not limited to, experience, skills, education, and certifications.)

KEY RESPONSIBILITIES:

General:

• Draft regulatory documents and participate in the development of regulatory strategies for various FDA activities, including pre-submissions, PMA, FDA meeting attendance, IDE, 510(k), etc., meeting requests, and questions for early-interaction packages to secure health authority guidance.
• Draft response templates to questions and inquiries issued by regulatory agencies.
• Ensure adherence to FDA or other appropriate regulatory guidelines regarding compliance.
• Provide guidance and training to less experienced medical writers in all aspects of regulatory document writing responsibilities.
• Write materials and methods section of study reports, evaluating the study data to assess whether the methods documentation meet the requirements of the study protocol.
• Coordinate with and assist Study Director, Pathologist, Veterinarian, as well as Contributing Scientists/Principal Investigators in the presentation of data and writing of report and/or sub-reports.
• Perform rigorous QC checks for data accuracy, internal consistency, and adherence to protocols, SOPs, and adherence to regulatory guidelines.
• Prepare file-searchable PDF version of the report deliverable (i.e., bookmarks).
• Establish and perform quality control review; copy editing, content editing, and number checking for other writers for draft, revised and final deliverables to ensure adherence to department standard.
• Coordinate and communicate with participating departments, sponsors and outside vendors to help ensure timely delivery, organization and generation of the preclinical study report.
• Assemble and proofread/copyedit study protocols prior to submission for Study Director signature.
• Prepare file-searchable PDF version of the report deliverable (i.e., bookmarks).
• Assist in the development of formats, templates, and general guidelines for documentation.
• Assist in the process improvement projects to enhance departmental efficiency, data collection, or data presentation.
• Assist in identifying and implementing software for document preparation and compliant regulatory submissions.
• Assist in the interview process.
• Perform all other related duties as necessary/assigned.

Process Optimization:

• Contribute to departmental goals by improving standard operating procedures (SOPs), document templates, and technology adoption.
• Assist in the coordination complex submission content to ensure messaging matches regulatory strategy.
• Maintain current knowledge of industry trends and best practices for medical writing and regulatory requirements.
• Experience with marketing authorization application regulatory submissions.

QUALIFICATIONS:

Required:

• Bachelor's or Master's degree in biological sciences, technical writing or equivalent field (with significant course work in biological sciences).
• 2-5+ years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, medical device, or CRO environment.
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
• Solid understanding of data analysis, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission.
• Ability to prioritize tasks and managing competing priorities in a fast-paced environment.
• Excellent problem solving, organizational, and analytical critical thinking skills.
• Excellent written and verbal communication skills.
• Strong attention to detail related to consistency, grammar, and formatting.
• Proficient in MS Office Suite and Adobe Acrobat.
• Makes decisions for assigned programs or functional areas, balancing priorities and resolving routine challenges; escalates high-impact or cross-functional decisions as needed.
• Facilitates cross-functional coordination for assigned programs or initiatives, ensuring alignment and timely execution of deliverables.

Preferred:

• Regulatory guidelines proficiency, including a strong understanding of FDA/ICH guidelines, GxP, and eCTD standards.
• Professional Certification: American Medical Writers Association (AMWA) Medical Writer Certified (MWC) or Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification (RAC).
• Technical authority: Recognized scientific and technical credibility that clients and internal teams trust on complex programs.
• Submission Strategy: Proven capability to lead content development for complex filings.
• This job requires talking, hearing, standing or sitting for long periods of time, typing, entering data into a computer, reaching with hands and arms, working in quiet area.

WORK ENVIRONMENT:

• General office working conditions, with generally quiet noise conditions.
• Exposure to laboratory areas with mild noise/odors.

COMMENTS:

This position may require (>20%) domestic and international travel or performing duties on weekends and/or holidays.

• The opportunity to help shape and grow the Regulatory and Medical Writing Department.

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.