Senior Medical Writer UCB Pharmaceuticals, Inc. -
Raleigh, NC
JOB DESCRIPTION:Clinical submissions documents in scope include: Phase 1-3 protocols and clinical study reports (CSRs); summary documents (including Integrated Summary of Safety [ISS], Integrated Summary of Efficacy [ISE], Clinical Overview, Clinical Summary), risk management plans (as needed), and clinical study summaries (for posting to study registries); and clinical parts of Investigational Drug Brochures, agency meeting briefing packages, INDs, IND, and EU Annual Safety Updates, and responses to agency questions; and other documents that may be assigned.It is the responsibility of the Senior Medical Writer to: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 Conference on 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. Provide process, content, and submission/document planning expertise to Clinical Submission Team, Clinical Satellite Team, and Clinical Trial Team. Advise team on resource utilization, efficiencies, timelines, and interdependencies.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 AreasWrite and prepare clinical submissions documents within a team environment.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 Conference on Harmonisation (ICH) compliant presentation.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.Review and comment on documents in clinical program (eg, protocols and statistical analysis plans) associated with project assignments.Act as Clinical Program Medical Writer (as assigned). Provide process, content, and planning expertise to Clinical Trial Team, Clinical Satellite Team, and Submission Team regarding document preparation, submission strategy and consistent scientific messaging. Advise team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies. Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style.Coordinate with other Clinical Program Medical Writers and 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 in an effort 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.Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced.Such other responsibilities and projectsQualifications:Five or more years experience in Medical Writing in the Biopharmaceutical industry. An advanced degree (e.g., MS, PhD, etc) may be considered in lieu of years of experience. Regulatory writing experience is preferred.Additional requirements include:Ability to work without close supervision.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.A high degree of familiarity with statistical and data output.Knowledge of the methods, techniques, and procedures of medical writing tasks.Prior CSR and Summary Document generation experience, preferably at a sponsor.Prior experience with submissions in Common Technical Document (CTD) format.Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).Detailed and experienced-based understanding of applicable regulations, Common Technical Document structure and content, including CSR and summary document content.
CareersInPharmaceutical.com - 12 months ago
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