Senior Manager, Regulatory and Medical Writing

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Regulatory and Medical Writing based in the United States.

This remote leadership role offers the opportunity to shape high-quality regulatory and medical writing programs within a data-focused clinical research environment. You will provide strategic and technical leadership across complex medical writing deliverables supporting pharmaceutical, biotech, and medical device development. The position combines hands-on subject matter expertise with people leadership, mentoring, client engagement, and project ownership. You will help teams navigate evolving regulations, writing standards, quality requirements, and emerging technologies. Success in this role requires strong judgment, organizational discipline, and the ability to resolve complex client and project challenges. It is an impactful opportunity to develop talent, strengthen delivery standards, and contribute to high-quality clinical and regulatory outcomes.

Accountabilities:

• Serve as a senior subject matter expert in regulatory and medical writing, maintaining a strong understanding of applicable regulations, guidance, writing standards, and evolving industry expectations.
• Provide guidance and mentorship to medical writers and managers, supporting professional development, identifying leadership opportunities, and helping build a strong and capable team.
• Provide immediate supervision to assigned team members, including allocating work, reviewing progress, checking deliverables, and supporting effective performance management.
• Lead or contribute to departmental initiatives and strategic projects, taking ownership of important programs beyond day-to-day team management.
• Act as a document subject matter expert across complex regulatory and medical writing deliverables, advising teams on appropriate writing styles, document requirements, and quality expectations.
• Support and mentor colleagues in the use of quality control processes, medical writing tools, training resources, and emerging technologies, including AI-assisted authoring solutions where appropriate.
• Interpret regulatory and organizational requirements and apply appropriate methods, techniques, and evaluation criteria to achieve high-quality project outcomes.
• Independently manage projects from initiation through completion, coordinating activities, timelines, deliverables, and stakeholder expectations.
• Identify, assess, and mitigate project risks, including evaluating client gaps and anticipating challenges that could affect successful delivery.
• Manage client meetings and CRM activities while maintaining clear communication and strong working relationships with stakeholders.
• Respond effectively to client feedback, ensuring appropriate follow-up, resolution, and communication throughout the engagement.
• Assess the downstream impact of regulatory, process, or deliverable updates and communicate relevant implications to project teams and leadership.

Requirements:

• Hold a college degree in a scientific, medical, clinical, or related discipline, with a master’s degree or PhD preferred; equivalent relevant professional experience may also be considered.
• Bring at least 6 years of experience in Regulatory and Medical Writing or a closely related field, with demonstrated expertise across complex medical writing activities.
• Have proven direct experience managing, mentoring, and developing Medical Writing professionals, including experience providing leadership and supervision to team members.
• Demonstrate strong managerial capabilities, with the ability to assign work, develop talent, provide guidance, and support team performance and growth.
• Possess a strong understanding of regulatory requirements and guidance relevant to medical writing, including familiarity with FDA, GCP, and 21 CFR Part 11 requirements.
• Bring hands-on knowledge of clinical trials, pharmaceutical development, scientific and clinical terminology, and the drug development lifecycle; CRO experience is preferred.
• Demonstrate expertise in medical writing styles and document types, including complex regulatory and clinical documents, with the ability to serve as a trusted subject matter expert.
• Be comfortable using MS Office applications and medical writing, quality control, and related project technologies.
• Demonstrate strong problem-solving, analytical, organizational, communication, and stakeholder-management skills, with the ability to anticipate client needs and resolve complex issues independently.
• Have the ability to manage multiple priorities, evaluate situations requiring in-depth organizational knowledge, and make sound decisions using appropriate methods and criteria.
• Demonstrate familiarity with ISO 9001 and ISO 27001 standards, preferably within a regulated clinical research or life sciences environment.
• Be comfortable adopting and supporting emerging technologies, including AI-assisted authoring tools where applicable.
• Be legally authorized to work in the United States without requiring visa sponsorship or a transfer of work authorization.

Benefits:

• Fully remote opportunity within the United States.
• Opportunity to work in a collaborative, supportive, and innovative clinical research environment.
• Leadership role with meaningful responsibility for team development, mentoring, and departmental initiatives.
• Exposure to complex regulatory and medical writing programs supporting pharmaceutical, biotechnology, and medical device development.
• Opportunities to work with evolving medical writing technologies, including AI-assisted authoring tools.
• Professional development and career growth through subject matter expertise, leadership responsibilities, and cross-functional initiatives.
• Opportunity to contribute to high-impact clinical research and regulatory submission activities.
• Collaborative environment focused on scientific excellence, quality, innovation, and employee development.
• Work alongside multidisciplinary professionals across a global clinical research organization.
• Salary is determined based on experience, qualifications, and the scope of the role; candidates are asked to provide their desired salary during the application process.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1