Sr Regulatory Medical Writer

Syneos Health, Inc.; Toronto; On-site; CAD 80,000 - 110,000; Full time

Job summary

Syneos Health is seeking a Sr Regulatory Medical Writer to join their team in Toronto. This role involves leading medical writing projects, mentoring junior staff, and ensuring compliance with regulatory standards. The successful candidate will possess a relevant bachelor's degree and exhibit proficiency in technical writing, alongside excellent communication skills. Join us to make a meaningful impact in the biopharmaceutical industry.

Benefits

Career development and progression

Technical and therapeutic training

Total rewards program

Qualifications

• Bachelor's degree in relevant field with writing experience.
• Deep knowledge of FDA and ICH regulations.
• Proficiency in English grammar and AMA style guide.

Responsibilities

• Manage medical writing activities for individual studies.
• Mentor less experienced medical writers.
• Develop clinical documents and reports for regulatory submissions.

Skills

Leadership

Proofreading

Interpersonal skills

Presentation skills

Technical writing

Education

Bachelor of Science degree

Bachelor of Arts degree

Tools

Word

Excel

PowerPoint

Job description

Updated: June 3, 2025
Location: Toronto
Job ID:25003699

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

- 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 study protocols and clinical protocol amendments;

- Clinical study reports;

- IND submissions and annual reports;

- Integrated summary reports;

- NDA and (e)CTD submissions;

- Investigator brochures, as well as;

- Clinical journal manuscripts, clinical journal abstracts, and client 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 commentson draft and final documents.

- Adheres to established regulatory standards, including but not limited to ICH-E3 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.

- 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 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 and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership 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.

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.

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

Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility.Impact and ContributionRoles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.Core Focus• Leading the clear and accurate completion of medical writing deliverables• Managing medical writing activities associated with individual studies• Coordinating these activities within and across departments• Completing a variety of documents, adhering to established regulatory standards• Coordinating quality and editorial reviews• Acting as peer reviewers for the internal team• Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency• Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs• Performing online clinical literature searches and complying with copyright requirements• Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff• Mentoring and leading less experienced medical writers on complex projects• Developing deep expertise on key topics in the industry and regulatory requirements• Working within budget specifications for assigned projects

Description

Sr Regulatory 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

- 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 study protocols and clinical protocol amendments;

- Clinical study reports;

- Patient narratives;

- Clinical development plans;

- IND submissions and annual reports;

- Integrated summary reports;

- NDA and (e)CTD submissions;

- Investigator brochures, as well as;

- Clinical journal manuscripts, clinical journal abstracts, and client 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 commentson draft and final documents.

- Adheres to established regulatory standards, including but not limited to ICH-E3 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.

- 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 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 and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership 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.

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

Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility.Impact and ContributionRoles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.Core Focus• Leading the clear and accurate completion of medical writing deliverables• Managing medical writing activities associated with individual studies• Coordinating these activities within and across departments• Completing a variety of documents, adhering to established regulatory standards• Coordinating quality and editorial reviews• Acting as peer reviewers for the internal team• Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency• Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs• Performing online clinical literature searches and complying with copyright requirements• Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff• Mentoring and leading less experienced medical writers on complex projects• Developing deep expertise on key topics in the industry and regulatory requirements• Working within budget specifications for assigned projects

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.