Principal/Senior Medical Writer

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

Serves as medical writing lead on clinical regulatory documents. Creates complete and quality drafts prior to each team review. Meets project deadlines. Produces documents that have few quality control (QC) findings.
Coordinates the review of appropriate functions (e.g., QC, source doc approval, formatting, etc.) involved in the document development.
Schedules and effectively leads and conduct kickoff meetings and review meetings with the team. Creates agendas and meeting minutes for each meeting.
Effectively communicates clinical regulatory document deliverables and writing process to team members. Holds team members accountable to agreed-upon project dates.
Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
Successfully and independently manages team to timeline; maintains sponsor awareness of delays, issues, and gaps to effectively manage the timeline and communicates appropriately to sponsor MW manager;