Role Description

The MWS Consultant plays a critical role in authoring and managing regulatory documents, supporting client regulatory strategies, and ensuring high-quality deliverables that align with client expectations and regulatory standards. This role is responsible for leading document development efforts, coordinating regulatory projects, and collaborating with cross-functional teams to meet diverse client needs across varying stages of development. The MWS Consultant serves as both a technical contributor and project owner, ensuring document accuracy, submission readiness, and adherence to regulatory requirements while maintaining strong client relationships and delivery excellence.

Work location may vary based on client needs and project requirements. Travel may be required to client sites or Syner-G offices depending on engagement expectations.

Key Responsibilities

• Author a variety of regulatory documents including Clinical Study Reports (CSRs), study protocols, and client submission materials.
• Lead the development of complex regulatory modules such as Module 2 summaries, Briefing Documents, and Orphan Drug, Fast Track, and Breakthrough Designation applications.
• Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards.
• 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 project 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.
• Support early-stage and smaller clients by contributing to regulatory strategy development.
• Collaborate with cross-functional teams to ensure the quality and accuracy of regulatory deliverables.
• 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

• Advanced degree in a life or health science discipline (e.g., M.S., PharmD, Ph.D., or M.D.) preferred.
• RAC certification beneficial.
• Strong foundation in medical writing, regulatory writing, and interpretation of scientific content.
• Ability to communicate complex scientific and regulatory information clearly and concisely, both in writing and verbally.
• Exceptional project and time management skills with the ability to manage multiple priorities and proactively adjust timelines.
• Strong critical thinking and data analysis skills to ensure scientific claims align with supporting evidence and regulatory expectations.
• High attention to detail with the ability to ensure consistency and accuracy across multiple document reviews.
• Patient and empathetic approach, particularly in cross-cultural and client-facing environments.
• Positive attitude toward feedback and continuous improvement.

Technical Skills

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Microsoft Teams, and MS Project.
• Familiarity with regulatory document management systems such as Veeva Vault.
• Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions.
• Experience with regulatory submissions and an understanding of global regulatory standards.

Essential Functions

• Physical demands include regular use of a computer keyboard and mouse; reaching with hands and arms; talking and listening.
• Frequent walking and sitting, as well as lifting and carrying objects such as books and files weighing up to 25 pounds.
• Occasional standing, stooping, or kneeling.
• Specific vision abilities required 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

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Ongoing recognition and career development opportunities.
• Generous flexible paid time off program.
• Company paid holidays.
• Flexible working hours.
• Fully remote or hybrid work options for some roles.
• Office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Legal Statement

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, 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 on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.