Syneos Health is hiring: Principal Medical Writer in California

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 places the customer and patient at the center of everything we do. 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.

• 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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Responsibilities

• Mentor and lead less experienced medical writers on complex projects, as necessary.
• Represent the Medical Writing department on clinical study teams, at conferences, meetings and for client presentations regarding a writing project.
• Advise clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
• Develop good working relationships with internal and external colleagues.
• Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develop or support a variety of documents, including but not limited to: 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; client presentations.
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Provide peer review comments to ensure clarity, accuracy, relevance and client objectives are met and quality standards are maintained.
• Adhere to regulatory standards (ICH-E3), SOPs, client standards, and approved templates; deliver projects on time and on budget.
• Conduct online clinical literature searches as applicable.
• Pursue ongoing professional development to keep pace with regulatory guidance and client expectations that affect medical writing.
• Understand budget specifications for assigned projects, work within budgeted hours, and communicate changes to medical writing leadership.
• Complete required administrative tasks within specified timeframes.
• Perform 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 and expertise.
• 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.

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, competencies, and proficiency for the role.

Benefits

• Company car or car allowance (where applicable).
• Health benefits to include Medical, Dental and Vision.
• Company match 401k and eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time; paid sick time compliance varies by location.

Syneos complies with all applicable federal, state, and municipal paid sick time requirements where applicable. The company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.