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[Hiring] Senior Medical Writer @Syneos Health Careers
Role Description
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 Oncology, Briefing Packages and Response to Agency Questions would be an asset. Position is open in the 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
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.
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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
- Plain language summaries
- Periodic safety update reports
- Clinical development plans
- IND submissions
- Integrated summary reports
- NDA and eCTD submissions
- Journal manuscripts
- 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
- Strong and proven expertise in Clinical document writing experience (Protocols, CSRs and IBs).
- Experience in Oncology, Briefing Packages and Response to Agency Questions is an asset.
Requirements
- Must be open to consider working EST/CST timezones.
Benefits
- 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
- Flexible paid time off (PTO) and sick time
Company Description
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.
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.
