Gsk
Biopharma
AssociateDirector,MedicalWriting
“Associate Director, Medical Writing at Gsk. Skills: Medical Writing, Clinical Pharmacology, Regulatory Submissions, Project Management. Lead planning, authoring and quality control of early phase clinical and regulatory documents. Coordinate cross-functional and external input”
What You'll Achieve.
positively impact the health of 2. 5 billion people; accelerating significant assets that meet patients’ needs; highest probability of success; uniting science, technology and talent to get ahead of disease together; progress your career; ensure alignment and regulatory readiness; increase quality and efficiency
Industry & Context.
What They're Looking For.
Must Have
Minimum 10+ years of experience including in early phase medical writing, project management skills, ability to deliver multiple documents on tight timelines, Excellent written and verbal communication skills, attention to scientific detail, Experience working in a global, matrixed environment, managing external vendors
Nice to Have
Advanced degree such as MSc, PhD, PharmD in pharmacology, Experience leading complex submissions, authoring modules 2. 7. 1 and 2. 7. 2, Familiarity with medical writing and submission tracking tools, Experience mentoring writers, leading cross-functional teams, Record of driving process improvements, introducing automation in writing workflows
What You'll Do.
authoring and quality control of early phase clinical and regulatory documents
Coordinate cross-functional and external input
Serve as lead author on complex submissions
Mentor and coach medical writers
Develop training materials for the team
Identify and implement process improvements
Apply digital tools and technology
Author and review documents
Maintain document trackers
Ensure documents meet regulatory requirements
Build working relationships with internal stakeholders and external authors
constructive feedback
Support continuous learning in the team
How You'll Work.
Team & Collaboration
Coordinate cross-functional and external input; Operate in a matrix-team; Build working relationships with internal stakeholders and external authors; Experience mentoring writers; leading cross-functional teams
Communication Scope
Excellent written and verbal communication skills; Collaborative communication; Provide clear, constructive feedback
Process & Methodology
project management skills, ability to deliver multiple documents on tight timelines, Lead planning, Maintain document trackers, Flag risks early to keep projects on schedule
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