Senior Medical Writer (FSP) - Clinical document writing experience (Protocols, CSRs and IBs)
Updated: YesterdayLocation: Remote, B, ArgentinaJob ID:********-OTHLOC-******DR
Senior Medical Writer (FSP) - Clinical document writing experience (Protocols, CSRs and IBs)
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.
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, eligive as Site Management (SM) primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to: Primary SM Sponsor contact Investigator and Bid Defense Meeting Internal and External study team calls Project-specific Audits / Inspections Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities Customize study‐specific SM Quality Management Documents, e.g. the Clinical Monitoring Plans (CMP)Oversee compliance to the CMP, including site visits,



outstanding trip reports and visit follow up lettersReview protocol deviations and visit action items to ensure that activities are conducted according to the CMP.Provide CRAs training all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as neededParticipate in the development and implementation of patient recruitment strategy in countries and sites assigned.Lead the tracking of recruitment and revision of site‐specific recruitment plans as needed to ensure enrollment stays on targetDrive efforts to improve the quality of site data and address any identified needs with action plans.Review data metrics to ensure data integrity and quality Track/measure SM deliverables to identify trends.Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as neededOversee TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on target and TMF is inspection readyFormulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressedReview/finalize trip reports according to Worldwide SOPs and expectationsMay perform site qualification, initiation, interim monitoring, and/or close out site visits as neededProvide a key role in problem solving and first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor as neededProactively identify and mitigate risksMay represent site management as primary contact on projectsConduct co‐visits where required to ensure quality of site, the CRA work and study procedures.Perform other duties as assigned.The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all‐inclusive.What you will bring to the roleExcellent interpersonal, oral and written communication skills in EnglishExcellent planning and organizational skills with effective time managementExcellent presentation skillsFlexibility to changeAbility to manage multiple and varied tasks with enthusiasmAbility to negotiate and influence with diplomacy in order to achieve resultsDemonstrate initiative and problem‐solving skills by offering solutions when obstacles are identifiedMust be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well‐defined instructions and procedures with minimal supervisionAbility to lead and motivate a team remotelyAbility to provide experience and input into process initiatives and development relating to monitoring and site management activitiesStrong customer focus,



ability to interact professionally within a sponsor contactExtensive understanding of clinical research principles and processStrong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirementsExperience in the study therapeutic indication/area Thorough understanding of standard operating proceduresProficient knowledge of Microsoft Office, eCRF, IVRS packagesProficiency with IxRS, CTMS and EDC systemsYour experienceFour‐year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of three years as a Senior Clinical Reical 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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📌 Senior Medical Writer (Fsp) - Clinical Document Writing Experience (Protocols, Csrs And Ibs)
🏢 Syneos Health
📍 Mendoza