CTM II - Sr CTM assigned to client LAtam (USA scope or local scope) - Mexico, Argentina, Brasil, Chile, Colombia - Remote 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 EVERYWHEREWhy 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.Job ResponsibilitiesResponsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
Oversees site interactions post activation through site closeout.
This may include patient recruitment, investigator payments or other related activities.May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.Participates and presents in key meetings such as Kick Off Meeting.




Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
This may include accompanying CRA team members to sites for observation or conflict resolution.Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.Responsible for development and ongoing maintenance of clinical study tools and templates, including the Cliy 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
We are looking for a Senior Medical Writer with strong and proven expertise in Clinical document writing experience (Protocols, CSRs and IBs).
In addition experience in Briefing Packages, Response to Agency Questions and Oncology would be an asset.Position is open in following countries, however candidates must be open to consider working EST/CST timezones:-Europe (UK, Poland, Romania, Spain, Hungary, Netherlands, Portugal and Serbia)- LATAM (Argentina, Brazil and Mexico)- US/Canada
Discover what our more than 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 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.
Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients.
Job Responsibilities




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%).
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📌 Ctm Ii - Sr Ctm Assigned To Client Latam (Usa Scope Or Local Scope) - Mexico, Argentina, Brasil, Chile, Colombia - Remote (Santa Fe)
🏢 Syneos Health
📍 Santa Fe