Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you re looking to be a part of a company with an unwavering commitment to improving patients lives and being a great place to work, we hope you ll explore our career openings and get to know Jazz Pharmaceuticals.
Primary Objective/ Purpose of Position:
As a key member of the document development team, the Clinical Document Quality Specialist is responsible for ensuring the quality of clinical, safety and regulatory documents created by R&D that are submitted to external stakeholders (ie, regulatory authorities).
Ensures that documents adhere to global quality standards and electronic publishing standards
- Work collaboratively with medical writers and representatives from other functional areas to ensure that all source information / data are appropriately reported in terms of accuracy and completeness and in accordance with project timelines
- Reviews clinical, safety and regulatory medical writing deliverables created in-house or by medical writing vendors, including but not limited to protocols, investigator brochures, clinical study reports, disclosure records, CTD summaries and regulatory responses
- Quality check documents (check document against source); fact or data check (verify data against source documents)
- Assess document to ensure formatting, internal consistency, spelling, grammar, syntax, lexicon are in accordance with agreed upon quality standards
- Provide quality finding feedback to document author
- Perform QC review of bookmarks and hyperlinks within documents queued for regulatory publishing
Creates, implements and maintains templates and associated guidance tools to allow authoring teams to quickly author quality documents that meet regulatory, corporate and industry needs / requirements.
- Create, maintain and implement document style and format guides
- Support medical writers in the production of document-specific templates, guidance documents and checklists, as appropriate
- Coordinate the review and approval process for new or updated guides and templates, in accordance with current R&D practices
- Facilitate implementation and use of template and guidance documents through interactions with key stakeholders within R&D
Participates in timelines, resourcing, performance and vendor management
- Participate in document timelines / resource planning within the clinical teams
- Support senior staff with prospective resourcing and budgeting
- Assist with vendor management and performance assessment relating to QC process
- Calculate and report monthly key quality metrics
Additional responsibilities for:
- Acts as a central resource on all medical writing format and style related issues
- Participates in program, project and submission teams, providing advice and guidance for optimal QC of documents
- Contributes to development, maintenance and implementation of medical writing best practices in relation to document standards, templates and document development
- Bachelor s or Master s degree in pharmacy, biological sciences or related disciplines
- At least 3-5 years of experience of working in the CRO/Pharma/Biotech industry in the GCP environment
- Exceptional English language skills and ability to edit complex material to ensure accuracy, clarity, and effectiveness
- A solid understanding of the clinical development process, including the documents that are required at each stage.
- Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
- Excellent written and oral communication skills and demonstrated problem-solving abilities
- Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Other Valuable Experience:
- Excellent organisational and time management skills.
- Attention to detail.
- Demonstrated ability to manage several projects simultaneously.
- Excellent interpersonal and influencing skills
- Ability to work independently and as a team member
- Ability to liaise with stakeholders across the organisation
- Ability to work to deadlines while maintaining focus on details and quality.
- Demonstrated ability to work collaboratively; demonstrated negotiating skills and resourcefulness.
- Applies good judgement and demonstrates initiative
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Associated topics: antibody, bacteria, dietary, dietician, drug, drug development, healthcare, kinesiology, patient, trauma