We're here because we want to build the future and transform patients' lives for the better.
At UCB, our people are our experiences and achievements, our passion and drive. That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.
An exciting journey lies ahead. Will you join us in pushing the boundaries of what's possible?
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
About us.
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.
At UCB, everything we do start with a simple question: "How will this create value for people living with severe disease?". We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.
Curious to know more? Please visit our website www.ucb.com.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
