Medical Writer II – Funding e-Request
Syneos Health
Medical Writer II – CSR Narratives
Syneos Health
full-time
Posted on:
Location Type: Hybrid
Location: Gurugram • 🇮🇳 India
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Mentors less experienced medical writers on projects, as necessary
- Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision
- Develops or supports a variety of documents including clinical study protocols and clinical study protocol amendments, clinical study reports, patient narratives, annual reports, and investigator brochures
- 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, addressing team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format
- Adheres to established regulatory standards, including ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and approved templates when completing medical writing projects, on-time and on-budget
- Performs on-line clinical literature searches, as applicable
- Working knowledge of drug development process and regulatory guidelines
- Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing
- Stays aware 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%)
Requirements
- Min 1 years of experience working in narratives with masters qualification and 2 years experience with Graduation
- Good experience in drafting and reviewing narratives
- 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
- 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
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical study protocolsclinical study reportsstatistical analysis plansnarratives draftingproofreadingregulatory guidelinesclinical literature searchesdrug development processdata interpretation
Soft skills
mentoringindependencepresentation skillsinterpersonal skillsleadership skillscommunication skillsattention to detailtime managementteam collaborationadaptability
Certifications
master's degreebachelor's degree