Syneos Health · 2 hours ago
Medical Writing Developer (Data Management - Clinical Programming)
United States
Full-time
Remote
Senior LevelSyneos Health is a leading biopharmaceutical solutions organization focused on accelerating customer success. The Medical Writing Developer will act as the Functional Lead for Data Management, coordinating activities and ensuring compliance with regulations and standard operating procedures while managing project resources and training staff.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
Coordinate the work of the assigned Data Management/Data Operations team
Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
Provides project specific training to internal and external audiences as required
Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
Plan, manages and requests resources for assigned projects
Develop and maintain project plans, specifications and documentation in line with SOP requirements
Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date
Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
Plans for and creates necessary documentation to support internal and external audits; participates in such audits
Trains and mentors data management staff
Prepares input for, and participates in proposal bid defense meetings
Maintains proficiency in Data Management systems and processes through regular training
Performs other work related duties as assigned. Minimal travel may be required (up to 25%)
Qualification
Required
Acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups
Coordinate the work of the assigned Data Management/Data Operations team
Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
Provides project specific training to internal and external audiences as required
Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
Plan, manages and requests resources for assigned projects
Develop and maintain project plans, specifications and documentation in line with SOP requirements
Maintains documentation on an ongoing basis and ensures that all TMF filing is complete and up to date
Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
Plans for and creates necessary documentation to support internal and external audits; participates in such audits
Trains and mentors data management staff
Prepares input for, and participates in proposal bid defense meetings
Maintains proficiency in Data Management systems and processes through regular training
Performs other work related duties as assigned. Minimal travel may be required (up to 25%)
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Michael Bonello
Executive Vice President and Chief Financial Officer
Michael Brooks
Chief Operating Officer
Recent News
2026-01-09
2025-12-01
Company data provided by crunchbase