Overview
Principal Medical Writer at Syneos Health. 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 the patient in all we do. We aim to simplify and streamline our work to be easier to work for and with. You may join in a Functional Service Provider partnership or a Full-Service environment, collaborating with passionate problem solvers to accelerate the delivery of therapies and change lives.
Work Here Matters Everywhere
- We are focused on developing our people through career development and progression, supportive line management, training, peer recognition and total rewards.
- We embrace a Total Self culture where you can authentically be yourself; we are dedicated to taking care of our people.
- We strive to build a diverse, inclusive environment where everyone belongs.
Job Responsibilities
- Mentors and leads less experienced medical writers on complex projects, as necessary.
- Represents the Medical Writing department on clinical study teams, at conferences, meetings and for client presentations related to a writing project.
- Advises clients and study teams on data presentation and production strategies to meet client objectives and ensure quality standards.
- Develops good working relationships with internal and external colleagues.
- Manages medical writing activities for individual studies, coordinating across departments with minimal supervision.
- Develops or supports a variety of documents including: clinical study protocols and amendments, clinical study reports, patient narratives, clinical development plans, IND submissions and annual reports, integrated summary reports, NDA/eCTD submissions, investigator brochures, clinical journal manuscripts and abstracts, and client presentations.
- Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
- Serves as peer reviewer to ensure clarity, relevance and quality that meets client objectives.
- Adheres to regulatory standards (including ICH-E3), SOPs, client standards, and approved templates; completes projects on time and within budget.
- Performs online clinical literature searches as applicable.
- Maintains ongoing professional development to align with regulatory guidance and client expectations.
- Understands budget specifications for assigned projects and works within budgeted hours, communicating changes to medical writing leadership.
- Completes required administrative tasks within specified timeframes.
- Performs other duties as assigned. Minimal travel may be required (less than 25%).
Qualifications
- Bachelor of Science with relevant writing experience, or Bachelor of Arts (Social Sciences, English or Communications preferred) with relevant scientific/medical knowledge.
- Extensive knowledge of English grammar with familiarity with AMA style guide.
- Understanding of FDA and ICH regulations and guidelines is strongly preferred.
- Demonstrated effective presentation, proofreading, interpersonal skills and a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to understand clinical research principles and to interpret and present clinical data and other complex information.
Benefits and Salary
The position offers benefits such as health coverage (medical, dental, vision), 401(k) with company match, eligibility for Employee Stock Purchase Plan, potential for commissions/bonus, flexible PTO and sick time, and a possible company car or car allowance. Benefit specifics vary by location and regulatory requirements.
Salary Range
$95,000.00 - $175,700.00