Senior Principle Medical Writer

Overview

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Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll 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, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
• Participate in cross-functional process improvement initiatives.
• Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

• Benefits for this position may include a company car or car allowance, Health benefits (Medical, Dental and Vision), Company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary depending on location. Syneos complies with applicable paid sick time requirements.
• Salary Range: $ - $ The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies, and proficiency for the role.

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. The Company may consider equivalent experience, skills, and/or education. The Company will determine what constitutes equivalence to the qualifications described above. Nothing herein should be construed to create an employment contract.

The language herein is intended to comply with obligations imposed by law in the countries in which it operates, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate to assist employees or applicants to perform essential functions.