Consultant I, Medical Writing

Syner-G; United States; Remote; USD 80,000 - 120,000; Full time

Benefits offered by this job

Flexible paid time off

Company-paid holidays

Annual incentive plan

Career development opportunities

Job summary

Syner-G is seeking a qualified professional to focus on regulatory documentation for clinical studies. The role involves authoring clinical study reports, developing regulatory strategies, and collaborating with cross-functional teams to ensure compliance.

The ideal candidate will possess an advanced degree in a life or health science and have substantial experience in regulatory submissions. This position offers flexibility with remote work options and a market-competitive salary.

Qualifications

• 3+ years of experience in the industry related to regulatory submissions.
• Proficiency in document management and regulatory standards.
• Strong writing and communication skills in scientific context.

Responsibilities

• Author regulatory documents including clinical study reports.
• Lead the development of complex regulatory documents.
• Coordinate timelines and client interactions.

Skills

Medical writing

Regulatory writing

Project management

Data analysis

Communication skills

Education

Advanced degree in life or health science

RAC certification

Tools

Microsoft Office Suite

Veeva Vault

MS Project

Job description

Work Location

The position is eligible for remote work based on company requirements, with no minimum in‑office requirement.

Key Responsibilities

• Author regulatory documents, including clinical study reports (CSRs), study protocols, and client submission materials.
• Lead development of complex modules such as Module 2 summaries, briefing documents, orphan drug, fast‑track, and breakthrough designation applications.
• Apply quality control and submission‑readiness processes to deliver high‑quality documents within agreed client timelines.
• Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands.
• Plan for and anticipate project challenges, update visual timelines, and maintain adherence to deadlines.
• Facilitate client interactions, including meetings, inquiries, and feedback discussions, while building and maintaining client trust.
• Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards.
• Collaborate with cross‑functional teams to ensure the quality and accuracy of regulatory documents.
• Contribute to the development of regulatory strategies for early‑stage and smaller clients.
• Provide guidance on tools, document management systems, and client SOPs.
• Engage in continuous learning through exposure to new document types, processes, and industry best practices under senior mentorship.

Qualifications and Requirements

Education

• Advanced degree (M.S., PharmD, Ph.D., or M.D.) in life or health science preferred.
• RAC certification beneficial.

Technical Experience

• 3+ years industry experience.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Teams, and MS Project.
• Familiarity with regulatory document management systems such as Veeva Vault.
• Experience with regulatory submissions and understanding of global regulatory standards.

Knowledge, Skills, and Abilities

• Strong foundation in medical writing, regulatory writing, and interpretation of scientific content.
• Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions.
• Effective written and verbal communication skills, with the ability to communicate complex scientific and regulatory information clearly and concisely.
• Exceptional project and time management skills, with the ability to prioritize multiple projects and adjust timelines proactively.
• Patient and empathetic approach, especially in cross‑cultural and client‑facing environments.
• Positive attitude toward feedback and a willingness to apply it for continuous improvement.
• Strong critical thinking and data analysis skills to ensure scientific claims align with evidence and regulatory requirements.
• High attention to detail, ensuring alignment and accuracy across multiple document reviews.

Essential Functions

Physical Demands: Regular use of a computer keyboard and mouse; reach with hands and arms; talk and listen. Requires walking, sitting, and occasional standing, stooping, or kneeling. Must lift and carry objects up to 25 pounds. Specific vision abilities include close vision and the ability to adjust focus.

Work Environment: Moderate noise level, indoor temperate environment, bright light levels conducive to minimal eye strain typical for an office environment.

Benefits

Compensation and benefits include a market‑competitive base salary, annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees enjoy generous flexible paid time off, company‑paid holidays, flexible working hours, and fully remote or hybrid work options for applicable roles. Physical work locations are available in Greater Boston, San Diego, CA, Boulder, CO, and India.

Legal Statement

Syner‑G is a proud Equal Employment Opportunity and affirmative action employer. All employment decisions are made without regard to race, color, creed, religion, sex, pregnancy, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or any other basis prohibited by applicable law. Syner‑G is an E‑Verify employer.