Overview
Senior Principal Medical Writer role at Syneos Health
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.
WORK HERE MATTERS EVERYWHERE
Responsibilities
* Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Syneos Health 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) (eg, 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.
Other information
The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, 401k match, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonuses, and flexible PTO and sick time. Paid sick time eligibility may vary by location. Syneos complies with all applicable paid sick time requirements.
Salary Range: $114,000.00 - $210,900.00
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.
Additional information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. The Company will determine what constitutes equivalent qualifications. This description is not an employment contract. Equal Employment Opportunity statements retained as applicable.
Summary
The Associate Director, Principal Medical Writer I is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and submission documents) accurately present data-driven messages in accordance with regulatory requirements. Writes or directs others to deliver high-quality documents that are scientifically rigorous, logically organized, and data-accurate. Mentors less experienced writers. Reports to a Director of Medical Writing or above.
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