Scientific and Medical Writing
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Dec 9 2020
In the Principal/Lead Scientific Writer position at GSK, we are seeking an individual who possesses enough experience and recognized expertise to train and coach staff on selected activities. Working in a matrix environment, they will act as the lead writer and project manager for Scientific Writing activities, process improvement initiatives, track KPIs, identify resource needs, promote best practices and continuous improvement within teams across Development sites (quality, processes, facilitate knowledge transfer and sharing lessons learned, identification and escalation of risks). Training/coaching team members and providing support in one or more exciting vaccine development programs at the US RDC [Research & Development Center] in Rockville, MD.
As responsible for Scientific Writing deliverables, the Principal/Lead Scientific Writer :
- 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 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.
- 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 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.
- 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:
- Post-graduate degree in life sciences or medical background or equivalent expertise
- Experience of executing market-size and market-share strategies
- Proficiency in basic immunology and area of assigned vaccine project.
- Advanced knowledge of scientific methodology in the design, conduct and description of clinical research.
- Expertise in analyzing and describing clinical results.
- Advanced knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP)/Regulatory requirements.
- Advanced knowledge of statistical principles used in clinical research
- Excellent command over English language (verbal and written).
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- PhD or equivalent
- 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 literacy.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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