Associate Director, Medical Writing

About the role

As an Associate Director of Medical Writing at Structuretx, you will play a pivotal role in shaping the narrative of our innovative therapies. This position is designed for a seasoned professional with extensive experience in medical writing, particularly within the biopharmaceutical sector. You will lead a team of writers and collaborate closely with cross-functional departments to ensure that our scientific and regulatory documents meet the highest standards of quality and compliance. Your expertise will be crucial in translating complex scientific data into clear, concise, and compelling content that supports our mission to advance transformative therapies.

Key facts

What you'll do

• Lead and mentor a team of medical writers, providing guidance on best practices and fostering professional development.
• Oversee the preparation and review of regulatory documents, including clinical study reports, protocols, and investigator brochures, ensuring they meet regulatory standards.
• Collaborate with clinical, regulatory, and scientific teams to gather and synthesize information for various documents, ensuring accuracy and clarity.
• Develop and implement writing strategies that align with project timelines and regulatory requirements, ensuring timely delivery of high-quality documents.
• Review and edit documents for clarity, consistency, and adherence to company and regulatory guidelines.
• Participate in the planning and execution of clinical trials, providing writing support for study-related documents and communications.
• Ensure compliance with industry standards and guidelines, including ICH and FDA regulations, throughout the writing process.
• Contribute to the development of training materials and resources for internal stakeholders regarding medical writing best practices.
• Stay updated on industry trends and regulatory changes that may impact medical writing and communicate these changes to the team.
• Facilitate cross-departmental collaboration to ensure alignment on project goals and writing objectives.
• Manage timelines and resources effectively to meet project deadlines while maintaining high-quality standards.
• Serve as a point of contact for external partners and regulatory agencies regarding medical writing inquiries and submissions.

Requirements

• A minimum of 7 years of experience in medical writing within the biopharmaceutical or biotechnology industry.
• Proven track record of writing and managing regulatory documents, including INDs, NDAs, and clinical study reports.
• Strong understanding of clinical trial processes and regulatory requirements.
• Excellent written and verbal communication skills, with the ability to convey complex scientific concepts to diverse audiences.
• Experience in leading and mentoring teams, with a focus on fostering a collaborative and productive work environment.
• Strong organizational skills and the ability to manage multiple projects simultaneously while meeting tight deadlines.
• Proficiency in using medical writing software and tools, as well as familiarity with electronic document management systems.
• Ability to work independently and as part of a team, demonstrating initiative and problem-solving skills.
• A degree in life sciences, medicine, or a related field; advanced degrees (e.g., PhD, MD) are preferred.

Nice to have

• Experience with therapeutic areas relevant to Structuretx's pipeline, such as oncology or rare diseases.
• Familiarity with statistical analysis and data interpretation in clinical research.
• Previous experience in a leadership role within a medical writing team.
• Knowledge of international regulatory guidelines and submission processes.
• Experience with electronic publishing and document formatting tools.

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and reference management software.
• Familiarity with medical writing software such as EndNote, Reference Manager, or similar tools.
• Strong analytical skills to interpret clinical data and present findings effectively.
• Excellent attention to detail and a commitment to producing high-quality work.
• Ability to adapt writing style to suit different audiences and document types.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel for meetings or conferences.
• The role offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development.
• Structuretx is committed to fostering a diverse and inclusive workplace and encourages applications from individuals of all backgrounds.
• Interested candidates can apply through the company's career portal at https://structuretx.bamboohr.com/careers/453.

Join Structuretx and be part of a team that is dedicated to advancing innovative therapies that make a difference in patients' lives. Your expertise in medical writing will be instrumental in driving our mission forward.