The Role:
The Manager of CTTD is a key role within our organization, reporting directly to the Director of CTTD. This position is responsible for managing the development and delivery of high-quality clinical and regulatory documents, from planning and coordination to the final draft. The individual in this role will work closely with the clinical development team, understanding and applying Disclosure procedures and concepts to process study details that support the broader objectives of our clinical development programs.
Here’s What You’ll Do:
Functional Knowledge: Understand and apply CTTD procedures and concepts for developing documents within a clinical development program. This includes but is not limited to:
Develop and implement departmental strategies: This includes setting goals and objectives for the CTTD team that align with the company's overall strategy.
Ensure compliance with regulatory guidelines: The Manager of CTTD should be responsible for ensuring that all documents produced by the team comply with international regulatory guidelines and standards.
Manage external vendors and consultants: This might include selecting vendors, managing contracts, and overseeing the quality of their work.
Develop templates: This can help ensure consistency across all submission documents produced by the CTTD team.
Provide training and mentorship to team members: The Manager of CTTD should be responsible for developing the skills and knowledge of their team members.
Participate in cross-functional teams: This can help ensure that the CTTD work aligns with the needs of other teams within the company.
Work within the established budget for the CTTD department: This includes planning the budget and monitoring expenses to ensure that the department stays within its budget.
Stay up-to-date with industry trends and changes in regulatory guidelines: This can help ensure that the medical writing team's work remains current and compliant.
Problem Solving: Solve problems by identifying and selecting solutions through the application of acquired technical experience, guided by precedents.
Impact: Contribute to the overall efficiency and effectiveness of the team, through clear communication of performance expectations, handling sensitive issues, and fostering a high-performance culture.
Here’s What You’ll Bring to the Table:
Education and Years of Experience: Advanced degree (preferred) with approximately 3 years of relevant experience OR bachelor’s degree with approximately 8 years of relevant experience.
Interpersonal and Communication Skills: Excellent written, verbal, interpersonal, analytical, and communication skills to effectively communicate and collaborate with all levels of the organization. Ability to interpret scientific content, prioritize multiple projects with evolving timelines.
Leadership Skills: Ability to mentor junior members of the team (if applicable).
Technical skills: Proficiency in disclosure software and a strong understanding of the technical aspects of the job. Proficiency in the use of standard industry software and tools.
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