Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) - Canada Remote Based

Job summary

The Senior Medical Writer leads the preparation of regulatory submission documents, including protocols, amendments, and clinical study reports, while ensuring scientific accuracy and adherence to regulatory standards. They also coordinate document reviews, mentor junior staff, and collaborate with cross-functional teams to meet project timelines and budgets.

Job details

Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) - Canada Remote Based Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities The role could be remote based from the following locations: US or Canada This Sponsor dedicated role will involve partnering closely with Clinical Scientist and will be focused on Protocols and Protocol Amendments. Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; 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. 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, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs. Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities. Mentors and leads less experienced medical writers on complex projects, as necessary. Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications: 3-5 years of relevant experience in medical writing, with proven experience in Protocol writing Experience working in the biopharmaceutical, device, or contract research organization industry required. Experience with late development Experience with Oncology/Hematology/Cell therapy. Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required. Experience writing relevant document types required. Experience in working with Veeva/CARA. Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style. 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.

What you’ll do

The Senior Medical Writer leads the preparation of regulatory submission documents, including protocols, amendments, and clinical study reports, while ensuring scientific accuracy and adherence to regulatory standards. They also coordinate document reviews, mentor junior staff, and collaborate with cross-functional teams to meet project timelines and budgets.

Requirements

Candidates must have 3-5 years of medical writing experience, specifically in protocol writing within the biopharmaceutical or CRO industry. Proficiency in FDA/ICH regulations, experience with oncology or cell therapy, and familiarity with tools like Veeva/CARA are required.

Benefits

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program

Listed skills

• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Medical writing
• Regulatory submission
• Protocol writing
• Oncology
• Hematology
• Cell therapy
• FDA regulations
• ICH guidelines
• Veeva
• CARA
• Clinical study protocols
• Clinical study reports
• AMA Manual of Style
• Scientific writing
• Project management
• Standard Operating Procedure
• Presentations
• Communication
• Templates
• Management
• English Language
• Coordinating
• Technical Support
• Leadership
• Writing
• Research
• Pre-Clinical Development
• Medical Affairs
• Customer Success Management
• Data Management
• Administrative Functions
• Statistical Analysis
• Legislation
• Grammar
• Regulatory Requirements
• Life Sciences
• Biopharmaceuticals
• Clinical Trials
• Cell Therapy
• Non-Disclosure Agreement (Intellectual Property Law)
• Annual Reports
• Informed Consent
• Information Sciences
• Brochures
• Commercialization
• Regulatory Affairs
• Electronic Common Technical Document
• Clinical Study Reports
• Drug Development
• Medical Writing

Job areas

• Healthcare
• Science & Research
• Consulting
• Regulatory Submission Specialist
• Medical Writer
• Authors and Related Writers
• Technical Writers

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