Medical Writing Lead

Sanofi

Budapest, Hungary

Join our global Clinical Sciences and Operation (CSO)’s Clinical Documentation department as Medical Writing Lead and you will oversee Medical Writers and Innovation Project Assistants within in Sanofi’s Budapest Hub. In this role you will focus on delivering high-quality outcomes and advancing excellence across all related functions. Core accountabilities include authoring of clinical study reports, protocols, clinical summaries, CTA, and enhancing processes and technologies vital to our medical writing operations. Your commitment and enthusiasm about people development and adept at fostering robust relationships with global functional leads will be desired.

Main responsibilities

Oversee the Medical Writing and Innovation Project Assistant employees and activities, with commitment to delivering high quality results and overcoming challenges with successful execution;
Act as liaison to global functional leads on business topics such as metrics, prioritization, and performance;
Foster employee development to build subject matter expertise and encourage collaboration with global functions to enhance knowledge sharing and drive process improvements;
Promote teamwork, quality, operational efficiency, and innovation;
Stay updated on evolving medical writing practices, regulatory and inspection readiness requirements to maintain industry leadership;
Foster a change-agile environment and act as key change agent for new processes and technologies;
Manage budgets and oversee initiatives to support legal requests, mergers, audits, inspections, and other organizational needs;
Provide mentorship to staff, manage hiring and training processes, and ensure performance goals are met effectively.

About you

Experience:

Min. 3-5 years of industry experience, including building and leading teams in a matrix environment;
Working knowledge of drug laws, regulations, and guidelines. Familiarity with drug development, regulatory or other guidelines pertaining to document standards and submission requirements are advantageous;
Organizational and process change management experience.

Technical skills:

Strong computer software skills- MS Office Suite;
Knowledge of electronic document management systems would be preferred.

Soft skills:

Strong management skills including leadership, prioritization, team inspiration, cross-cultural sensitivity, delegation, empowerment, and accountability coupled with strategic and innovative thinking;
Proven ability to manage changes, negotiate and influence others, and resolve conflict;
Understanding of business considerations (basic finance, human resources);
Ability to adapt to needs of an evolving business environment (e.g., regulatory requirements, corporate structure and processes, customer focus, technological advances);
Ability to work across time zones and cultures.