Safety Writing Scientist

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To strengthen our global Patient Safety and Medical Management (PSMM) group we are looking for a talented individual to fill the position of Safety Writing Scientist.

As a Safety Writing Scientist, you will have the following responsibilities:

• Lead preparation of Patient Safety and Medical Management deliverables, including planning, contributing to analysis strategy, writing, presentation when necessary, and review/approval of documents and deliverables in scope which include DSUR, SMR, PSUR, SSAR, RMP, PAER, SRM Strategy document, regulatory responses, submission documents, relevant and other regulatory/safety annual reports.
• Provide mentorship to relevant vendors and oversee the work, ensuring the final deliverables meet the UCB quality guidelines.
• Perform literature review and summary of literature for AR, RMP, epidemiology, product renewals, safety evaluations
• Assure quality and consistency across Patient Safety and Medical Management deliverables, including compliance with regulatory requirements and compliant with agreed and defined timelines
• Prepare ECMS templates to be compliant for regulatory submissions globally and act as ECMS superuser to provide guidance for Patient Safety and Medical Management colleagues and contract organizations
• Develop strategies for data searches in support of document preparation
• Actively participate in team/product meetings to give input based on scientific expertise and awareness of business implications
• Ability to present analyzed relevant adverse event/scientific/clinical/epidemiological data to a variety of audiences in an effective manner
• Project manage and champion continuous improvement initiatives and dedicated areas of expertise (e.g. Hub)
• Collaborate in the planning, preparation, and review of epidemiologic/scientific manuscripts, abstracts, posters, etc for submission to scientific journals/conferences including generation of lay language summaries for patients as necessary
• Bringing value to patients by having ability to identify areas of risk to Patient Safety and Medical Management and report findings to stakeholders/PSU/line manager, etc

About you

You should have:

• Bachelor’s Degree
• Demonstrate accountability for actions taken, learning from successes and failures and seeking constructive feedback
• Ability to gather data from relevant sources using appropriate methods and logic, and to interpret, analyze, draw meaningful conclusions and clearly present scientific and technical data in verbal and written format
• Ability to project manage deliverables in a matric environment with competing priorities
• Ability to manage own work: ability to prioritize, plan and organize multiple assignments and to work under strict timelines
• Effective communication and building of relationship with internal and external stakeholders
• Understanding of principles in partnership management and ability to contribute in the collection and reporting of information with regards to metrics under analysis
• Coordination of key activities in safety communication, including contributing to the strategy in such communication and integrating cross-functional input
• Understanding of global pharmaceutical regulations and best practices and ability to translate them into meaningful, practical and feasible procedures
• Use of standards tools effectively and autonomously