Manager​/Associate Director, Medical Writing - Regulatory

Overview

Manager/Associate Director, Medical Writing - Regulatory

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and patient, with a focus on simplifying and streamlining work to improve both partner experience and efficiency.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies to change lives.

Why Syneos Health

• We are passionate about developing our people through career development and progression; supportive management; training; peer recognition and total rewards.
• We are committed to a Total Self culture where you can authentically be yourself and be supported.
• We value diversity of thought, backgrounds, cultures and perspectives to foster belonging.

• Project-specific management responsibilities for medical writing staff. Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Advises staff on administrative policies, technical problems, priorities, and methods.
• Reviews and edits departmental work products for completeness, accuracy, and quality; assumes responsibility for quality of departmental outputs.
• Ensures adherence to Sponsor objectives and quality standards.
• Supports MW leadership in planning, development and implementation of document development strategies; participates in quarterly business updates.
• Assists with preparation of budgets and timelines for medical writing activities (full-service clinical projects and stand-alone medical writing projects).
• Assists with budgeting, revenue, invoicing, and forecasting as requested.
• Contributes to departmental metrics by tracking, maintaining and reviewing project metrics.
• Supports business development by assisting with proposal and costing development, bid defenses and customer meetings.
• Builds and maintains relationships with internal and external customers.
• Leads cross-functional teams and addresses issues that arise.
• Reviews performance of medical writing personnel (direct reports).
• Develops and maintains departmental SOPs and templates and acts as resource for implementation.
• Participates in planning, writing, and assembly of medical writing deliverables as needed.
• Performs senior reviews of medical writing deliverables, including reviews of statistical analysis plans and tables/figures/listings.
• Performs other duties as assigned. Minimal travel may be required (up to 25%).

Note:

The description does not specify explicit qualifications or required years of experience. Please refer to the official posting for detailed requirements.

Benefits may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) with company match, eligibility for an Employee Stock Purchase Plan, eligibility for commissions/bonus, flexible PTO and sick time, and compliance with applicable paid sick time requirements where required.

Salary Range: $95,000.00 - $

The base salary range reflects anticipated ranges for this position and may vary based on qualifications, skills, competencies, and proficiency for the role.