Senior Medical Writer; Scientific writer & Quality

Position: Senior Medical Writer(Scientific writer & Quality check)
Description

Senior Medical Writer(Scientific writer & Quality check)

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

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

JOB SUMMARY

Serves as a senior medical writer on clinical study or regulatory or publication project teams. Writes, edits, and coordinates content for clinical/regulatory/scientific while serving as primary technical contact with the internal team and the client.

JOB RESPONSIBILITIES

Mentors and leads less experienced medical writers on complex projects, as necessary.
Acts as lead for assigned writing projects.
Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Develops or supports a variety of documents that include, but not limited to:
Clinical journal manuscripts, clinical journal abstracts, posters, and oral presentations.
Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Serves as peer reviewer on internal review team providing review comments on draft and final documents.
Adheres to established regulatory standards, including but not limited to Journal/congress specific guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
Performs on-line clinical literature searches, as applicable.
Familiarity with figure-creation and data visualization software, including tools such as Graph Pad Prism and Adobe Illustrator, for developing high-quality scientific figures and graphics.
Familiarity with publication planning software e.g. Datavision and Pub Connect (Veeva Vault Promomats)
Reviews deliverables for scientific accuracy, data and referencing quality, appropriate style, and correct branding of scientific/medical assets.
Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
Completes required administrated tasks within the specified time frames.
Performs other…