FSP Associate Director Medical Writing

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an FSP Associate Director Medical Writing based in India.

The Associate Director of Medical Writing will provide strategic and operational leadership for regional Medical Writing teams, overseeing people, projects, and departmental performance. This role is responsible for ensuring high-quality scientific and regulatory documentation is delivered on time and in line with client expectations and applicable guidelines. The successful candidate will lead resource planning, recruitment, staff development, budgeting, and operational improvements while supporting the department's continued growth. Working closely with internal functions, external clients, and senior stakeholders, they will help resolve complex challenges and strengthen service delivery. The position also contributes to business development, project pricing, and the expansion of Medical Writing capabilities. It offers the opportunity to shape regional operations within a collaborative, global clinical research environment.

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.