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Medical Writer

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  65148

Medical Writer

UCB Biosciences

Raleigh, NC

Help us transform patients’ lives.

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

 

Job Summary  

Clinical submissions documents in scope include: Phase 1-4 protocols and clinical study reports (CSRs), summary documents, risk management plans, clinical parts of Investigator’s Brochures, INDs, and other documents that may be assigned.

It is the responsibility of the Medical Writer to:

  • Perform quality checks and authoring support to writing functions assets.
  • Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Council for Harmonisation (ICH) compliant presentation.
  • Prepare clinical submission documents for a regulatory audience, within a team environment, according to UCB SOPs and templates.
  • Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner.
  • Participate in the development of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards to foster open communication, quality, efficiency, and cost-effectiveness of clinical document generation to support the delivery of high-quality documents within realistic and ambitious timelines. Share expertise within Medical Writing and therefore across Therapeutic Areas.

 

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.
  • Coordinate with 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.
  • Write and prepare clinical submissions documents within a team environment.
  • Manage the review and approval process of clinical submissions documents; notify team of targeted review responsibilities. Generate consensus among reviewers, resolve conflicting comments, and facilitate discussions in an efficient manner.
  • Coordinate with other Medical Writers as needed to maintain consistency across documents within a project and across indications.
  • Participate in the development of processes and tools related to authoring and reviewing of clinical documents.
  • Continually share best practices to create higher quality documents more efficiently.
  • Maintain and demonstrate comprehensive knowledge of drug development process and applicable regulatory guidelines.
  • Maintain and demonstrate 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
  • 3 years of experience in scientific or medical writing in the Biopharmaceutical industry.
  • An advanced degree (e.g., MS, PhD, etc.) may be considered in lieu of years of experience.

 

Competencies

  • Ability to work under stress.
  • Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
  • Ability to work within an international team.
  • Must be detail-oriented, thorough, and methodical.
  • Excellent written and verbal communication skills.
  • Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
  • Excellent problem-solving capabilities and organizational skills.
  • Knowledge of medical, pharmaceutical, and clinical research concepts.
  • Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
  • Familiarity with statistical and data output.
  • Knowledge of the methods, techniques, and procedures of medical writing tasks.
  • Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
  • Understanding of applicable regulations, Common Technical Document structure and content, including CSR content.
  • Understanding of applicable regulations and guidelines (eg, Code of Federal Regulations, European Directive, and International Conference on Harmonisation).
  • Strong computer skills; proficiency in MS Word.
  • Ability to travel both domestically and internationally as business necessitates. 

 

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.

 


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