Sr. Manager, Medical Writing

About the role

As a Sr. Manager of Medical Writing at Artivabio, you will play a pivotal role in the development and execution of high-quality regulatory documents that support our innovative gene therapy products. This position requires a strategic thinker with a strong background in medical writing and an understanding of the regulatory landscape. You will lead a team of writers, ensuring that all documents are not only scientifically accurate but also aligned with the company's goals and regulatory requirements.

Key facts

What you'll do

• Oversee the preparation and review of clinical study reports, investigator brochures, and other regulatory submissions to ensure compliance with regulatory standards.
• Collaborate closely with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to gather necessary information and insights for document creation.
• Lead and mentor a team of medical writers, providing guidance on best practices in writing and regulatory submissions.
• Develop and implement standard operating procedures (SOPs) for medical writing to enhance efficiency and consistency across documents.
• Ensure that all documents are scientifically sound, clearly articulated, and tailored to meet the needs of various stakeholders, including regulatory agencies.
• Manage timelines and deliverables for multiple projects simultaneously, ensuring that all deadlines are met without compromising quality.
• Conduct thorough reviews of documents prepared by team members, providing constructive feedback and facilitating revisions as necessary.
• Stay updated on industry trends and regulatory changes that may impact medical writing practices, ensuring that the team is well-informed and compliant.
• Participate in the development of training materials and workshops to enhance the skills of the medical writing team.
• Represent the medical writing function in project meetings and contribute to strategic planning discussions related to product development.
• Collaborate with external vendors and consultants as needed to support writing projects and ensure adherence to quality standards.
• Contribute to the continuous improvement of the medical writing process by identifying areas for enhancement and implementing innovative solutions.

Requirements

• A minimum of 7 years of experience in medical writing, with a strong focus on regulatory submissions in the pharmaceutical or biotechnology industry.
• Proven track record of managing a team of writers and leading projects from inception to completion.
• In-depth knowledge of regulatory requirements and guidelines (e.g., ICH, FDA, EMA) related to clinical documentation.
• Exceptional writing and editing skills, with the ability to convey complex scientific concepts in a clear and concise manner.
• Strong organizational skills and the ability to manage multiple projects and deadlines effectively.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams.
• A Master's degree or higher in a relevant scientific discipline (e.g., life sciences, pharmacology, or related field) is preferred.

Nice to have

• Experience in gene therapy or advanced therapies is a significant advantage.
• Familiarity with electronic document management systems and regulatory submission platforms.
• Previous experience in a start-up or fast-paced environment, demonstrating adaptability and innovation.
• Certification from a recognized professional organization (e.g., AMWA, EMWA) is a plus.
• Knowledge of statistical analysis and biostatistics would be beneficial.

Skills & tools

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and reference management software.
• Familiarity with electronic submission systems (e.g., eCTD) and document management tools.
• Strong analytical skills and attention to detail to ensure accuracy in all written materials.
• Ability to work independently and as part of a team, demonstrating initiative and leadership.

Practical notes

• The specific location for this role is currently unknown, but it may involve remote work or relocation.
• The salary offered will be competitive and based on the candidate's experience and qualifications.
• Visa sponsorship is available for qualified applicants, making this an excellent opportunity for international candidates.
• Interested candidates can apply through the provided link to submit their application and resume for consideration.

META

Company: Artivabio

Title: Sr. Manager, Medical Writing

Listed

location: Unknown

Job type: Full-time