Lead Scientific Writer
Post-graduate degree in life sciences or medical background or equivalent expertise
PhD in life sciences
Demonstrated understanding of complex scientific information & skills to communicate information to various target audiences
Experience in writing multiple complex documents in varied disease areas, the job requires a higher level of responsibility in producing high quality documents through coordinating others at a project level
Proficiency in basic immunology and area of assigned vaccine project.
Demonstrates advanced knowledge of scientific methodology in the design, conduct and description of clinical research.
Demonstrates expertise in analyzing and describing clinical results.
Excellent organization skills to coordinate and manage geographically dispersed multicultural teams
Understands the organization of scientific documents.
Possesses advanced knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP)/Regulatory requirements.
Possesses advanced knowledge of statistical principles used in clinical research
Possesses very good computer skills and general computer literacy.
Excellent command over English language (verbal and written).
We are seeking a Scientific Writer for our new U.S. R&D Center in Rockville, Maryland. You will have the opportunity to be on the ground floor of a new organization and site, and you will be part of a new culture of some of the best scientific minds in vaccine research. Come deliver the GSK Vaccines strategy by driving vaccine R&D projects through innovation, collaboration, cutting edge science, exceptional people, and end-to-end quality performance.
- Responsible for Scientific Writing deliverables of assigned projects, oversees, coordinates and/or writes documents to support operational and strategic goals of such as study reports, concept protocols and study protocols clinical summary modules, global epidemiology plans and briefing documents. Ensures a consistently high quality through all documents produced by the team.
- Provides knowledge expertise to ensure deliverables (regardless of who writes it) are of consistently high scientific standards, with a logical flow in the presentation and interpretation of information throughout the project (inconsistencies should be escalated so risks may be transparently assessed).
- Promotes and provides information support in terms of strategic input to GSK Vaccines’ Clinical Development Plans.
- Leads implementation of continuous improvement through exercises such as lessons learned. This includes implementing best practices of/lessons learned from other writing teams and RDCs.
- Overview of project workload to anticipate bottle necks and specific resource issues. Resource gaps (or surplus) are communicated to facilitate even distribution of work throughout the scientific writing function.
- Assess and escalate risks to the appropriate level in addition to communicating opportunities the manager.
- Resolution of conflicts in priority or opinions from reviewers/approvers to ensure alignment of stakeholder (including the Clinical Research and Development Leader, [CRDL])
- Promotes knowledge sharing knowledge of the Scientific Writers in the project. Coaches and develops Associate Scientific Writers and Scientific Writers in all areas of accountabilities and ensure their integration into the team / company. Give information on training needs of his/her team to the Manager, Scientific Writing. Provides mentorship which develops skills and strengths of junior/newly hired members of the team as well as Provide feedback/information to his/her team members on projects and specific activities.
- Build capability by refining and expanding activities to optimize benefits of co-location or remote working. This may include new areas of regulatory support, or building more robust quality/consistency in a transversal environment. Where the lead writer coordinates other writers, the work assigned should match the capability of the individual, with more experienced writers assigned more complex or novel tasks.
- Ensure compliance with legal, quality and other regulatory standards through management monitoring and KPI reporting, proactively escalating risks to facilitate mitigation.
Location: Rockville, Md
You may apply for this position online by selecting the Apply now button.
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