Associate Director of Medical Writing
Site Name: Home Worker - USA
Posted Date: Feb 2 2023
GSK is seeking a motivated Associate Director of Medical Writing who is passionate about science and eager to contribute to vaccine development at a global organization. This important role is an opportunity to ensure the preparation of quality documents in support of one or more exciting vaccine development programs.
This position is based at our US Research and Development Center (RDC) in Rockville, Maryland, but remote working may be possible for those in other geographic locations. Experience developing documents necessary for this position include clinical concept protocols/protocols, informed consents, clinical study reports, investigator brochures and documents supporting submission to regulatory authorities.
The chosen candidate must be flexible working efficiently in a matrix environment across time zones (EST) (e.g., with colleagues based in the United States, Europe, and India)
This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities of the role include the following:
- Oversees, coordinates and/or writes documents of a consistently high quality to support operational and strategic goals.
- Provides expert knowledge to ensure deliverables (with inputs from the matrix team) are of consistent 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, regulatory submission writing and responses to questions from regulatory authorities.
- Tracks key performance indicators and 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.
- Overviews 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.
- Assesses and escalates risks to the appropriate level in addition to communicating opportunities the manager.
- Resolves 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.
- Builds 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 AD coordinates other writers, the work assigned should match the capability of the individual, with more experienced writers assigned more complex or novel tasks.
- Ensures compliance with legal, quality and other regulatory standards through management monitoring and KPI reporting, proactively escalating risks to facilitate mitigation.
We are looking for professionals with these required skills to achieve our goals:
- 5+ years of medical writing and project management experience
- Master's degree in a science/medical field
- 5 years experience (extending across these areas): working with clinical trials, executing market-size and market-share strategies, working with basic immunology and areas of assigned vaccine project, working with scientific, methodology in the design, conduct and description of clinical research, analyzing and describing clinical results, working with the International Committee for Harmonization (ICH) / Good Clinical Practice (GCP)/Regulatory requirements, working with statistical principles used in clinical research
If you have the following characteristics, it would be a plus:
- Good understanding of complex scientific information & skills to communicate information to various target audiences
- Excellent organization skills to coordinate and manage geographically dispersed multicultural teams
- Understands the organization of scientific documents
- Possesses computer skills and general computer literac
- Familiarity with navigating electronic Trial Master Files (eTMFs) (i.e., Veeva Vault)
- Possess strong verbal and written communication skills
We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
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