Sr. Manager, Medical Writing - Delivery & Excellence

The Role:

The Senior Manager of Medical Writing Delivery & Excellence is a high-impact role that demands a dynamic blend of expertise in both traditional medical writing and technological innovation. Reporting directly to the Senior Director of Medical Writing Delivery & Excellence, the chosen individual will not only be responsible for delivering high-quality clinical and regulatory writing—from the meticulous planning and coordination stage to the delivery of the polished final drafts—but will also drive the development and adoption of cutting-edge tools and processes to enhance medical writing practices and clinical trial transparency.

Here’s What You’ll Do:

• Functional Knowledge: Apply an in-depth conceptual and practical knowledge of concepts, theories, and principles of medical writing and regulatory writing within a clinical development program.

• Innovation: Support initiatives to identify, evaluate, and implement innovative tools and technologies that optimize medical writing processes and enhance transparency in clinical trials.

• Operations: May support operational processes essential to the departmental function.

• Document Planning: Develop and manage comprehensive, strategic document plans for clinical and regulatory submissions.

• Project Management: Oversee the timely and efficient progress of medical writing deliverables, ensuring that all deadlines are met.

• Cross-Functional Collaboration: Work closely with cross-functional teams to ensure alignment and integration of clinical and regulatory documents. Ensure seamless integration of new systems and methodologies into the existing framework of practices.

• Regulatory Compliance: Ensure all written documents comply with regulatory, industry, and corporate guidelines and standards.

• Data Interpretation: Interpret and present clinical data and other complex information.

• Quality Control: Implement and oversee quality control processes for writing and reviewing clinical and regulatory documents.

• Document Updates: Regularly update and revise documents as necessary to reflect current information and meet regulatory requirements.

• Problem Solving: Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.

• Impact: Solve complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information.

• Develop and Implement Departmental Strategies: Provide input into goals and objectives for the medical writing team that align with the company's overall strategy.

• Line Management: Responsible for management of direct reports (if applicable)

Here’s What You’ll Bring to the Table:

• Education: Bachelor’s degree with a minimum of 3 years of medical writing experience and 5 years of tool and/or system development and/or implementation in medical writing, drug development, or a related industry.

• Industry Experience: Proven experience in clinical development, regulatory affairs, or medical affairs.

• Industry Experience: Proven experience in writing and editing clinical and regulatory documents for submission to global regulatory authorities. Experience building and/or adapting technology to support medical writing systems and processes.

• Interpersonal Skills: Excellent interpersonal skills, with the ability to guide others either internally with other areas or externally with vendors and cross-functional team members to adopt a different point of view. Ability to explain difficult or sensitive information; work to build consensus

• Leadership Skills: Ability to manage the daily activities of multiple supervised individuals; adapt functional plans and priorities to meet short-term service and/or operational objectives. Ability to lead functional projects or programs; Mentor and collaborate with colleagues with less experience

• Business Expertise: Knowledge of best practices and how medical writing integrates with others within organization sub-function; is aware of the competition and the factors that differentiate them in the market.

• Communication Skills: Exceptional written and verbal communication skills, with the ability to clearly convey complex scientific information.

• Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.

• Technical Skills: Proficiency in Microsoft Office and familiarity with medical writing software.

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