Sr Medical Writer
4 weeks ago
Description
Senior 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 comments on 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
What we’re looking for
- 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.
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.
The annual base salary for this position ranges from $60,930 to $115,100. 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.
Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
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.
-
Principal/Sr Medical Writer
2 weeks ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior 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...
-
Sr. Medical Writer
5 months ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior 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...
-
Sr Medical Writer
4 months ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior 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...
-
Sr Medical Editor
4 weeks ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior Medical Editor 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...
-
Sr Medical Editor
4 weeks ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior Medical Editor 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...
-
Principal Medical Writer
1 week ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription 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...
-
Experienced Clinical Research Associate
2 weeks ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior Clinical Research Associate I 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...
-
Sr Clinical Research Associate
6 months ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior Clinical Research Associate I 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...
-
Sr CRA II
3 weeks ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior Clinical Research Associate II 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...
-
Sr Clin Ops Specialist
4 months ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Senior Clinical Operations Specialist 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...
-
Sr Director of Operations RWLP
4 months ago
Quebec City, Quebec, Québec, Canada Syneos Health Full timeDescription Director of Operations II, RWLP 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. Every day we perform better because of how we work together, as one...
-
Principal/Sr Medical Writer
2 weeks ago
Quebec City, Canada Syneos Health Full timeDescription Senior 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...
-
Sr Medical Writer
4 weeks ago
Quebec City, Canada Syneos Health Full timeDescription Senior 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...
-
Sr Medical Writer
1 week ago
Quebec City, Canada Syneos Health Full timeDescription Senior Medical Writer (Regulatory) 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...
-
Senior Medical Writer
4 weeks ago
Quebec City, Canada Syneos Health Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Writer to join our team at Syneos Health. As a Senior Medical Writer, you will be responsible for creating high-quality medical content for our clients, including clinical study protocols, clinical study reports, and other regulatory documents.Key ResponsibilitiesMentor and lead less experienced...
-
Senior Medical Writer
4 weeks ago
Quebec City, Canada Syneos Health Full timeJob SummaryAs a Senior Medical Writer at Syneos Health, you will be responsible for leading complex medical writing projects and mentoring less experienced writers. You will work closely with cross-functional teams to develop high-quality documents, including clinical study protocols, reports, and submissions. Your expertise in medical writing, regulatory...
-
Sr. Medical Writer
5 months ago
Quebec City, Canada Syneos Health Full timeDescription Senior 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...
-
Senior Medical Writer
4 weeks ago
Quebec City, Canada Syneos Health Full timeJob SummaryAs a Senior Medical Writer at Syneos Health, you will be responsible for creating high-quality medical content for various projects. This includes developing clinical study protocols, clinical study reports, patient narratives, and other documents. You will work closely with cross-functional teams to ensure that all content meets regulatory...
-
Sr Medical Writer
4 months ago
Quebec City, Canada Syneos Health Full timeDescription Senior 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...
-
Medical Writer Lead
7 days ago
Quebec City, Canada Syneos Health Full timeCompany OverviewSyneos Health is a leading 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...
-
Sr Medical Editor
4 weeks ago
Quebec City, Canada Syneos Health Full timeDescription Senior Medical Editor 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...
-
Sr Medical Editor
4 weeks ago
Quebec City, Canada Syneos Health Full timeDescription Senior Medical Editor 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...
-
Principal Medical Writer
1 week ago
Quebec City, Canada Syneos Health Full timeDescription 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...
-
Senior Medical Editor
3 weeks ago
Quebec City, Canada Syneos Health Full timeAbout the RoleWe are seeking a highly skilled Senior Medical Editor to join our team at Syneos Health. As a key member of our medical writing team, you will be responsible for ensuring the accuracy and quality of our regulatory documents.Key ResponsibilitiesMaintain familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that...
-
Sr. Account Manager
5 months ago
Quebec City, Canada EightSix Network Full timeJob Description Day-to-Day Insight Global is looking for a Sr. Account Manager to join our client locally in Montreal, QC. This is a full-time, permanent role that is % remote. The successful candidate should be highly knowledgeable within industrial sized electric motors (medium to high voltage). You will be working with an existing book of...
-
Senior Medical Editor
4 weeks ago
Quebec City, Canada Syneos Health Full timeJob SummaryWe are seeking a highly skilled Senior Medical Editor to join our team at Syneos Health. As a Senior Medical Editor, you will be responsible for maintaining familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.Key...
-
Quebec, Canada Amgen Full timeb>Career Category Medical Services Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. p> Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation,...
-
Quebec, Canada Amgen Full timeCareer Category Medical Services Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the...
-
Experienced Clinical Research Associate
2 weeks ago
Quebec City, Canada Syneos Health Full timeDescription Senior Clinical Research Associate I 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...
-
Sr Clinical Research Associate
6 months ago
Quebec City, Canada Syneos Health Full timeDescription Senior Clinical Research Associate I 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...
-
Sr CRA I
3 months ago
Quebec City, Canada Syneos Health Full timeDescription Senior Clinical Research Associate I 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...
