FSP Associate Director Medical Writing

Accountabilities • Oversee the day-to-day operations of the regional Medical Writing group, including workload management, departmental resources, project staffing, recruitment, training, performance management, and personnel matters.

• Lead, motivate, and develop managers and medical writers, ensuring clear communication of departmental goals, priorities, and performance expectations.

• Manage departmental budgets, monitor spending, and support financial planning and forecasting.

• Identify opportunities to develop and implement new departmental processes, standards, and operational practices.

• Oversee projects managed by direct reports, acting as the first point of escalation for project risks and complex delivery issues.

• Advise teams on contractual and budget matters for complex projects and identify potential out-of-scope work early to support appropriate project management.

• Participate in project launch meetings, review meetings, project team discussions, and audits as required.

• Support business development and senior management in securing new opportunities by preparing and delivering client presentations, developing new Medical Writing projects, and managing project pricing.

• Build strong relationships across departments and identify opportunities for collaboration with functions such as Phase I Medical Writing, pharmacokinetics (PK), biostatistics, pharmacovigilance, and regulatory teams.

• Lead the resolution of complex client management issues, addressing risks and escalating matters to senior management when appropriate.

• Oversee the preparation and senior review of complex medical writing documents when required.

• Maintain knowledge of applicable standard operating procedures (SOPs), client directives, and current guidelines governing clinical trials, documentation, and regulatory submissions, providing guidance to teams as needed.

• Champion operational excellence, process improvement, innovation, and new ideas that support the department's continued development.

Requirements

• Bachelor's degree in a science-related discipline; an advanced degree such as a PharmD, PhD, or Master's degree is preferred.

• At least 10 years of relevant professional experience, or an equivalent combination of education, training, and directly related experience.

• At least 5 years of management experience, with a demonstrated ability to lead and develop teams.

• Strong leadership capabilities, including performance management, coaching, mentoring, training, delegation, and staff motivation.

• Excellent project management skills, including project planning, timeline development, resource allocation, and departmental workload forecasting.

• Strong knowledge of global and regional medical writing and regulatory requirements for clinical trials, marketing authorization, and late-phase procedures.

• In-depth knowledge of at least one specialist area, such as preclinical, therapeutic, regulatory, or submission-related Medical Writing.

• Knowledge of budgeting, forecasting, departmental financial management, and project finances.

• Strong understanding of business principles, including contracts, proposals, and project pricing.

• Ability to develop innovative ideas and lead process improvements within Medical Writing operations.

• Excellent communication, negotiation, and presentation skills, with the ability to represent the department in client discussions, bid defenses, capability presentations, and audits.

• Strong interpersonal, problem-solving, judgment, and decision-making skills, with the ability to influence clients, senior leaders, and cross-functional stakeholders.

• Ability to manage complex client relationships, resolve operational challenges, and support a changing business environment.

• Willingness to travel occasionally to domestic and international locations, as required.

Benefits

• Fully remote working arrangement.

• Standard Monday-to-Friday working schedule.

• Opportunity to lead regional Medical Writing teams and contribute to global clinical research projects.

• Exposure to cross-functional collaboration with clinical, regulatory, pharmacokinetics, biostatistics, and pharmacovigilance specialists.

• Opportunities to influence departmental strategy, operational excellence, and business development.

• Professional growth through leadership responsibilities and involvement in complex medical writing and regulatory initiatives.

• Collaborative international working environment focused on scientific quality, innovation, and continuous development.

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