Safety Writing Scientist
il y a 1 semaine
**Make your mark for patients**
We are looking for a **Safety Writing Scientist** to join us in our **Patient Safety & Medical Management** team, based in any of our Brussels (Belgium), Slough (UK) or Raleigh (US) offices.
**About the role**
Scientific analysis and writing acumen to effectively articulate for benefit-risk assessments, safety risk management strategies, safety signal assessments, regulatory submissions, aggregate reports, and publications.
Lead, project manage, and contribute to projects (including mentoring of vendor) as assigned to deliver the project in accordance with global regulatory submission requirements (for external documents), within planned timelines (and budget as appropriate), and according to required standards of quality and compliance.
As assigned, lead a hub of expertise in the Safety analysis and writing team on an area of interest for the Patient Safety Medical Management team, which may include technical oversight of vendor or processes, being Subject Matter Expert on key activities, etc
**Who you’ll work with**
You will report into the Senior Safety Writing Scientist Team Lead
**What you’ll do**
- 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, BRAMS 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
I**nterested? For this position you’ll need the following education, experience and skills**:
- 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 manage own work: ability to prioritize, plan and organize multiple assignments and to work under strict timelines
- Understanding of principles in partnership management and ability to contribute in the collection and reporting of information with regards to metrics under analysis
- Understanding of global pharmaceutical regulations and best practices and ability to translate them into meaningful, practical and feasible procedures
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
**Learn more** about sustainability at UCB and how it is integrated into our business approach.
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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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