Associate Director, Medical Writing Technology and Content Architecture

Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support.

Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.

Synterex is seeking an organized, motivated, and collaborative individual to lead our Medical Writing Technology and Content Architecture team, which oversees the development of our artificial intelligence (AI) and other tools and software.

The Associate Director, Medical Writing Technology and Content Architecture will partner with client teams to understand requirements and elements for execution of potential applications for our software in Medical Writing, Clinical Development, Clinical Operations, Data Management, Quality, Biostatistics, Regulatory, and Program Management and facilitate Synterex execution of timely, well-planned, and high-quality templates and programmed outputs.

The Associate Director, Medical Writing Technology and Content Architecture will also ensure the products meet client and agency guidelines, both broadly and as regards the use of AI, to support drug development under brisk timelines, as well as ensuring the documentation of training and procedures for the products.

This position involves the management of both internal and external resources and relationships.

Location : Fully remote position, but must be able to attend key meetings on site with clients as requested.

Essential Duties & Responsibilities

• Champion the development and integration of technology solutions in medical writing, including AI-based tools, natural language processing, and structured content authoring
• Collaborate with internal and client teams to identify and build user cases and intentions that improve content architecture and delivery;

develop and execute on the product roadmap on time and within budget

• Lead projects using agile and other project management methodologies to ensure timely and successful implementation of software development initiatives
• Navigate legal, intellectual property, and data privacy and security concerns associated with integrating AI and technology in medical writing
• Evaluate and document the business impact and return on investment of technology initiatives for clients and stakeholders
• Foster a culture of continuous learning and innovation within the medical writing team, providing guidance on best practices in technology and content architecture.
• Drive the attraction and retention of top talent and help develop trainings and presentations to create buy-in for AI and the evolving role of the medical writer
• Oversee the work of junior writers contributing to technology-driven medical writing initiatives
• Enhance Synterex presence with relevant professional organizations

Requirements

• Experience (8+ years) as a medical writer in the CRO / biotech / pharmaceutical field, or equivalent
• Experience (2+ years) of experience in programming, AI, and technology application in a medical writing or similar context.
• Advanced degree in a relevant field (ie, Life Sciences, Data Science, Computer Science) required.
• Expertise in global guidelines and regulations for drug development, including ICH GxP and US / ex-US regulatory requirements
• Expertise with Microsoft Word and other Microsoft applications
• Expertise with document management system s
• Ability to work both independently and collaboratively in the face of competing priorities
• Service-oriented and proactive approach to project management and familiarity with project management methodologies, including agile
• Excellent conflict management and negotiation skills
• Strong written and verbal communication skills
• Track record of outstanding leadership and mentorship in the medical writing and quality assurance fields

For further information or to apply, please reach out to careers@synterex.com.

Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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