Principal Medical Writer - Belgium

Make your mark for patients.

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 Medical Writing Team, we are looking for a talented individual to fill the position of:Principal Medical Writer – Braine l’Alleud, Belgium.

As a Principal Medical Writer, you will:

• Lead or contribute to initial or supplemental drug applications (NDAs, BLAs, MAAs, Article 46s, INDs, ODAs, Type II Variations, Breakthrough Drug Requests, Fast Track Applications).
• Author clinical submission documents, including m1.20 general investigative plans, m2.5 clinical overviews, m2.7 clinical summaries (biopharmaceutical and bioanalytical data, clinical pharmacology, efficacy, safety), m5.3.5.3 integrated summaries (efficacy, immunogenicity, safety), clinical sections of briefing documents and risk management plans, response to agency questions, pediatric investigational plans/pediatric study plans, and clinical evaluation reports.
• Author high-risk clinical documents where turn-around time is critical (informed consent forms for rare disease indications, study concept documents, and protocol amendments).
• Provide oversight for partners who deliver high-quality clinical documents (investigator brochures; protocols and CSRs for phase 1-4 clinical, device, combination products, PASS, and prospective NIS/RWE studies).

You like to work in anenvironmentwhere you can:

• Play an active role throughout submission and lifecycle management.
• Provide expertise and continuity across the value chain of one or more assets.
• Work on early-phase and late-phase assets.
• Work with international teams.
• Work on innovative cross-functional initiatives.
• Have opportunities for professional development.
• Share expertise within Medical Writing by coaching/mentoring Junior and Senior Medical Writers.
• Have the flexibility to work from home and the office (UCB re-opening status is based upon local laws and regulations).

You willcontributeby:

• Acting as Clinical Program Medical Writer (CPMW), thereby providing process, content, and planning expertise to clinical teams regarding document preparation, submission strategy, and consistent style and scientific messaging.
• Write and prepare clinical submissions documents for a regulatory audience, within a team environment, according to UCB SOPs and templates.
• Manage the review and approval process of clinical submissions documents, which includes notifying team of targeted review responsibilities, generating consensus among reviewers, resolving conflicting comments, and facilitating discussions in an efficient manner.
• Coordinating with other CPMWs and MWs as needed to maintain consistency across documents within a project and across indications.
• Ensuring critical review and interpretation of clinical efficacy and safety data for appropriate, medically relevant, and SOP/GCP/ICH-compliant presentation.
• Fostering open communication, quality, efficiency, and cost-effectiveness of clinical document generation to support the delivery of high-quality documents within ambitious timelines.
• Review and comment on documents in clinical program (eg, protocols and statistical analysis plans) associated with project assignments.
• Liaising with vendors/external contractors to ensure timelines and quality of product when the writing of a document is outsourced.
• Advising teams on medical writing resource utilization, efficiencies, timelines, and interdependencies.
• Supporting the departmental goal to develop best-in-class processes, tools, and standards by leading/participating in the development of processes and tools related to document authoring, management, and quality control.
• Continually sharing best practices to create higher quality documents more efficiently.
• Maintaining and demonstrating expert knowledge of drug development, applicable regulatory guidelines, and company/project-specific guidelines for the generation of clinical submissions documents, including SOPs, templates, and document writing conventions and styles.

Interested? For this position you’ll need the followingeducation, experience and skills:
Minimum Qualifications:

• Bachelor’s or Master’s degree and 6+ years’ experience in medical writing in the biopharmaceutical industry.
• Ability to manage rapidly changing priorities and aggressive timelines.
• Ability to think independently and adapt to working in a multicultural environment without close supervision.
• Ability to apply principles across various situations and appropriately applying judgment to making changes.
• Mastery of the English language with a comprehensive understanding of English grammar and punctuation.
• Experienced-based understanding of eCTD structure and content, including CSR and summary document content.
• Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
• In-depth understanding of applicable regulations and guidelines (eg, CFR, ED, ICH, GCP).

Preferred Qualifications:

• Ph.D. with regulatory medical writing experience.
• Clinical safety document authoring experience (Summary of Clinical Safety, Integrated Summary of Safety).
• Experience in the therapeutic areas of immunology and neurology.
• Firsthand knowledge of working within international teams.
• Thorough involvement with submissions in eCTD format.

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.

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.