Full-Time Medical Writer
The medical writer contributes to the preparation of high-quality clinical documents (e.g., protocol synopses and protocols, clinical study reports, and Investigator Brochures) and collaborates with other departments such as Clinical Development, Development Operations, Biostatistics and Regulatory Affairs in the planning and preparation of documents within the assigned time frames. The medical writer will support the implementation of new templates, technologies and process improvement initiatives to increase the efficiency and effectiveness of Mallinckrodt’s Medical Writing group. This role is preferably in-house with 2 days’ work from home.
· Communicate timelines, documents needed and process standards to team.
· Interpret and explain data from a variety of sources.
· Comply with internal and external processes, SOPs, and appropriate guidelines.
· Interact with a cross-functional team through the document development process related to authoring and reviewing of clinical documents.
· Authoring regulatory documents, including but not limited to: clinical study reports (CSRs), Investigator Brochure(s), and other regulatory documents.
· Leading the writing review process and resolving issues, errors, or inconsistencies with pertinent team members to ensure timely completion and quality of assigned 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.
· Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) compliant presentation.
· Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced.
· Experience of eTechnology related to regulatory submissions activities is preferred (eCTD, EDMS, Life Cycle Management, collaborative authoring and reviewing tools, and templates)
· Experience-based understanding of applicable regulations and guidelines (e.g. Code of Federal Regulations [CFR], European Directive and International Conference on Harmonization [ICH]).
Experience / Skills:
· BA/BS within a scientific discipline, advanced degree (e.g., PharmD, PhD, MD) preferred.
· 2+ years of medical writing experience within the pharma/biotech/device/CRO industry.
· Familiarity with Regulatory Agency guidelines.
· Prior CSR and protocol generation experience.
· Demonstrated ability to collaborate and influence peers to achieve project deliverables
· Ability to exercise independent judgement in analyzing data.
· Strong computer skills: proficiency in MS Word.
· Ability to work without close supervision.
· Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
· Ability to work well within a diverse team.
· Must be detail-orientated, thorough and methodical.
· Exceptional written and verbal communication skills.
Office based minimum of 3 days per week and work remotely up to 2 days per week
How to ApplyTo apply, please click on the below link: https://mallinckrodt.wd5.myworkdayjobs.com/MallinckrodtCareers/job/US-Specialty-Brand-Headquarters---USA501/Medical-Writer_JR000009761-1
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