Principal Medical Writer

Syneos Health, Inc.; Morrisville (NC); On-site; USD 95,000 - 176,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Principal Medical Writer in Morrisville. This role requires developing clinical documents and managing writing activities while mentoring junior writers. The ideal candidate will have a strong background in scientific writing, proven regulatory knowledge, and exceptional communication skills, contributing to the delivery of life-changing therapies.

Benefits

Health benefits including Medical, Dental, and Vision

Company match 401k

Eligibility for Employee Stock Purchase Plan

Flexible paid time off (PTO)

Potential for commissions/bonus based on performance

Qualifications

• Extensive knowledge of English grammar and familiarity with AMA style guide.
• Ability to interpret and present clinical data.
• Understanding of FDA and ICH regulations strongly preferred.

Responsibilities

• Mentors less experienced medical writers on complex projects.
• Manages medical writing activities for individual studies.
• Develops a variety of clinical documents: protocols, reports, and submissions.

Skills

Effective presentation skills

Proofreading skills

Interpersonal skills

Understanding of regulations and guidelines

Education

Bachelor of Science degree in relevant writing experience

Bachelor of Arts degree in Social Sciences, English, or Communications

Tools

Word

Excel

PowerPoint

Job description

Updated: Yesterday
Location: Morrisville
Job ID:25003251

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

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

$95,000.00 - $175,700.00

Description

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 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

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

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 various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

• 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 and on data 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 that include but not limited to: o Clinical study protocols and clinical protocol amendments; o Clinical study reports; o Patient narratives; o Clinical development plans; o IND submissions and annual reports; o Integrated summary reports; o NDA and (e)CTD submissions; o Investigator brochures, as well as; o Clinical journal manuscripts, clinical journal abstracts, and client presentations.

• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

•Serves as peer reviewer providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.

• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as company SOPs, 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.

• Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.

• Understands budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

• Completes required administrated tasks within the specified timeframes.

• Performs other work-related 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 a familiarity with AMA style guide.

• Understanding of FDA and ICH regulations and guidelines strongly preferred.

• Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team-oriented approach.

• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.

• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your pastexperience doesn’t align perfectly, we encourage you to apply anyway. At times, we take intoconsideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health is a leading 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

Phone: [phone]
Fax: [phone]
Toll-Free: 866 462 7373

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: [e-mail] One of our staff members will work with you to provide alternate means to submit your application.