Client Dedicated Safety Writer II

Responsibilities

• Conduct data review, authoring, and quality review on clinical trial and marketed product safety writing deliverables

• Project manage low and moderate complexity safety deliverables such as PADERs, DSURs, PSURs/PBRERs and dRMPs

• Serve as primary point of contact for assigned safety writing deliverables

• Ensure tasks follow company policies, contractual agreements and applicable regulations

• Lead kick-off meetings, manage client communications, data requests, budgets and metrics

Requirements

• Bachelor's degree or equivalent qualification

• 5+ years of relevant experience, or equivalent combination of education and experience

• Knowledge of ICH and US aggregate safety reporting formats

• Strong data interpretation and medical-scientific writing skills

• Strong critical thinking and problem solving skills

• Ability to meet strict deadlines with limited supervision

• Proficiency in Microsoft Office including Outlook, Word and Excel

• Strong English oral and written communication skills

About the Company

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Its brands include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.