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Medical Writing Specialist

Company: UCB Inc.
Location: Raleigh
Posted on: January 17, 2020

Job Description:


At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in this pioneering adventure?

To strengthen our Patient Value Team, based in our RTP Office in Raleigh, NC , we are looking for a talented individual to fill the position of: Medical Writing Specialist.

You like to work in an environment where you can:

Job Summary

Global Medical Writing (GMW) contributes to the global clinical development of innovative medicines for the treatment of patients with severe diseases by delivering high-quality, scientifically-sound, and timely submission-related documents. This role performs quality checks and authoring support to writing functions, thereby contributing to the successful development, registration in key regions, and commercialization of new drugs and biologic agents.

Clinical submissions documents in scope include: Phase 1-4 protocols and clinical study reports (CSRs), summary documents, risk management plans (as needed), patient narratives, and clinical parts of Investigational Brochures, agency meeting briefing packages, INDs, and responses to agency questions, lay summaries, and redacted documents; and other documents that may be assigned.

Major Accountabilities

* Provide support to writing functions to ensure timely, high-quality deliverables in compliance with Standard Operating Procedures (SOPs), FDA, EMEA, ICH, and national and local regulations, as applicable.

* Manage and perform quality check of clinical submissions documents which includes data verification, verification of document completeness and consistency within a document and between related documents, spelling and grammar checks (as needed), reference checks, and verification that a document is consistent with company and project-specific writing conventions and styles.

* Provide expertise on process, content, checklists, efficiencies, timelines, and interdependencies.

* Assist in preparation of clinical submission documents by incorporating text edits/comments, in-text tables based on statistical outputs (Tables, Figures, and Listings), and project-specific style sheet standards.

* Manage and write minor clinical study protocol amendments (as needed) and minor CTD Sections (eg, List of Synopses).

* Participate in template development for clinical submission documents to ensure regulatory requirements, style requirements, and publishing specifications are met.

* Such other responsibilities and projects that the company may assign.

* Coordinate with other Medical Writing Specialists as needed to maintain consistency across documents within a project and across indications. Identify trends in quality deficiencies and recommend corrective actions.

* Act as a Lead Medical Writing Specialist on projects (as assigned). Track project timelines in order to ensure that all QC timelines across a project are met.

* Use functions of EDMS and PleaseReview for quality review, electronic formatting, compiling and finalizing of medical writing deliverables.

* Mentor, coach, and/or otherwise assist in the training and development of other Medical Writing Specialists.

* Maintain and demonstrate expert knowledge of company- and project-specific guidelines for the generation of clinical submissions documents, including SOPs, templates, and document writing conventions and styles.

Education and Qualification

* Bachelor's Degree Required


* Demonstrated ability to work without close supervision.

* Ability to work within an international team setting.

* Ability to work under pressure.

* Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.

* Must be detail-oriented, thorough, and methodical.

* Exceptional written and verbal communication skills.

* Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.

* Exceptional problem-solving capabilities and organizational skills.

* Exceptional proofreading skills.

* Ability to focus on the details in a document without losing sight of the document messaging.

* Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.

* Intermediate knowledge of medical, pharmaceutical, and clinical research concepts, including a comprehensive understanding of the clinical trial procedures and drug development process.

* A high degree of familiarity with statistical and data output.

* Expert knowledge of the methods, techniques, and procedures of medical writing tasks.

* Intermediate understanding of applicable regulations and guidelines (eg, Code of Federal Regulations, European Directive, and ICH) including CTD structure and content, CSR and summary document content.

* Strong computer skills; proficiency in MS Office Suite, and Electronic Document Management Systems (EDMS).

* Ability to travel both domestically and internationally as business necessitates.

* Ability to coach, train, and/or mentor more junior colleagues.

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach from discovery to development to delivery is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

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.

Keywords: UCB Inc., Raleigh , Medical Writing Specialist, Healthcare , Raleigh, North Carolina

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