FSP Associate Director Medical Writing

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Associate Director Medical Writing - Make an Impact at the Forefront of Innovation.
The Associate Director Medical Writing oversees the regional Medical Writing staff and projects, ensuring the delivery of quality products within agreed timelines. This role involves assisting in the development of the Medical Writing organizational structure, as well as recruiting, training, and motivating staff to achieve performance excellence. Additionally, the Associate Director helps develop and manage regional operating budgets and identifies new business opportunities and Medical Writing projects. The Associate Director collaborates both internally and with external clients to resolve complex problems and meet client deliverables and needs. Furthermore, the Associate Director leads operational excellence initiatives and drives process improvements within the department.

What You'll Do:
• Manage the operation of a Medical Writing group to include management of workload, departmental resources and allocation of staff to projects, recruitment, development, training, performance, and personnel issues for managers and writers.
• Engage and motivate staff, communicate departmental goals and priorities.
• Monitor spending against departmental budget and manages to the budget allocated.
• Identify need for, and promote development of, new departmental processes or standards.
• Provide oversight of projects led by direct reports and are first line of escalation for project risks. Advise direct reports on contract and budget issues for complex projects; assist in identifying out of scope project support in a timely manner. Participate in project Launch Meetings, Review Meetings, Project Team meetings, and audits as required.
• Assist business development and senior management in securing new business by preparing and making presentations to clients. Identify and develop business opportunities involving new Medical Writing projects. Manage the pricing of projects for Medical Writing.
• Build relationships with other departments and seek opportunities to collaborate with other functions for mutual benefit (e.g. Phase I medical writing, PK, biostatistics, PVG, regulatory). Actively support a changing environment and provide creative, novel ideas for taking the organization forward.
• Provide leadership in handling complex client management issues. Address and resolve, or escalate complex issues and risks to senior management if appropriate. May prepare complex documents and provide senior review.
• Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current guidelines regarding clinical trials, documents and other submissions and provide guidance to others as needed.


Education & Experience Requirements:
• Bachelor’s degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience.
• 5+ years of management responsibility
• Proven leadership skills
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:
• Strong leadership skills with the ability to manage people including performance, training, mentoring, directing and motivating staff
• Excellent project management skills, including the ability to plan and manage projects, develop timelines, allocate resources, and forecast departmental workload
• Excellent knowledge of global/regional medical writing/regulatory requirements for clinical trials, marketing authorization and late phase procedures, with in-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory, submissions.
• Knowledge of budgeting, forecasting, and departmental and project finances
• Excellent understanding of business principles, including contracts and proposals
• Innovation and leadership in developing new ideas related to Medical Writing, including process improvements
• Excellent communication, negotiation, and presentation skills to represent the department in a range of situations including bid defenses, capabilities presentations, and audits and to communicate influentially with clients, corporate leaders, and across functional areas
• Excellent interpersonal skills including problem solving, judgment, and decision-making skills.


Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations, frequent travels both domestic and international.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.