Principal Medical Writer Job at Syneos Health in Wyoming

Overview

Principal Medical Writer

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 centers the customer and the patient. We continually look for ways to simplify and streamline our work to make Syneos Health easier to work with and 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 to innovate as a team and help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Work here matters everywhere.

Why Syneos Health

• We are passionate about developing our people through career development, progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally, and we are dedicated to taking care of our people.
• We continuously build the company we want to work for and with our customers by valuing diversity of thoughts, backgrounds, cultures, and perspectives to create a sense of belonging.

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 presentations to the client regarding a writing project.
• Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.
• Develops good working relationships with internal and external colleagues.
• 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 including: clinical study protocols and amendments; clinical study reports; patient narratives; clinical development plans; IND submissions and annual reports; integrated summary reports; NDA and (e)CTD 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 improve clarity, accuracy, relevance and ensure client objectives are met and quality standards are maintained.
• Adheres to regulatory standards, including ICH-E3 guidelines, SOPs, client standards, and approved templates when completing medical writing projects, on time and on budget.
• Performs online clinical literature searches as applicable.
• Maintains professional development to keep pace with regulatory guidance and client expectations affecting medical writing.
• Understands budget specifications for assigned projects, works within budgeted hours, and communicates 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 degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications preferred) with relevant scientific and/or medical knowledge.
• Extensive knowledge of English grammar with familiarity with AMA style guide.
• Understanding of FDA and ICH regulations and guidelines strongly preferred.
• Demonstrated effective presentation, proofreading, interpersonal skills and a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Familiarity with principles of clinical research and ability to interpret and present clinical data and other complex information.

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Marketing, Public Relations, and Writing/Editing
• Industries: Biotech and Pharmaceutical Research

Salary and Benefits

Salary Range: $95,000.00 - $175,700.00

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, and proficiency for the role.

Benefits may include a company car or car allowance, health benefits (Medical, Dental, Vision), 401k with company match, eligibility for Employee Stock Purchase Plan, eligibility to earn commissions/bonus, and flexible PTO and sick time. Paid sick time eligibility varies by location; Syneos complies with applicable paid sick time requirements.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, and supported studies across hundreds of sites and trial patients. No matter your role, you’ll be encouraged to take initiative and challenge the status quo in a dynamic environment. Learn more at the company site.

No external links included in this refined description.

Additional information: Tasks, duties, and responsibilities are not exhaustive. The company may assign other tasks as needed. The foregoing is intended to comply with applicable laws and is not a contract. The company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations where appropriate.