Medical Writing Specialist
Company: UCB Inc.
Posted on: January 17, 2020
HELP US TRANSFORM PATIENTS\' LIVES.
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:
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
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
* 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
* 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
* 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
* 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
* 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
* 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
* 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
* Strong computer skills; proficiency in MS Office Suite, and
Electronic Document Management Systems (EDMS).
* Ability to travel both domestically and internationally as
* Ability to coach, train, and/or mentor more junior
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
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
Didn't find what you're looking for? Search again!