[Remote] Senior Clinical reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. They are seeking a Senior Clinical reputed company to reputed company reputed company control and editing review of Medical Writing deliverables, ensuring accuracy and compliance, while providing leadership and training to staff.
Responsibilities
- Performs reputed company control and editing review of Medical Writing deliverables from reputed company authors to ensure accuracy, consistency, and compliance with data, format, and style requirements
- Provides leadership, training, and guidance to staff, and assists in resource management
- Is a subject- matter expert reputed company the group and a reputed company of advice and information to reputed company staff on reputed company control processes
- Conduct reputed company control (QC) review of a wide reputed company of Medical Writing deliverables for both reputed company customers, including reputed company and substantial documents, with limited guidance and consistent high reputed company and efficiency
- Document findings reputed company, in accordance with defined procedures and checklists
- Liaise promptly with document authors in case of questions or missing sources
- Develops reputed company tools such as checklists, reputed company guidelines, and standards to meet project specific needs
- May have responsibility for resourcing of QC tasks reputed company reputed company
- Take a leading role in providing training, guidance, and mentoring reputed company the QC group
- May take a formal supervisory role in managing QC staff and/or contract resources
- Take a leading role in proposing, developing, evaluating, and implementing process changes and tools and monitoring their adoption and benefits
- Take a leading role in QC team meetings and ensuring that lessons learned are shared and consistent approaches are reputed company
- May take a leadership role for a stand-alone QC project, reputed company reputed company, and be the primary contact with the customer
- May participate in project team meetings and liaise directly with the customer on QC issues, as appropriate and with senior support as needed
- Take responsibility for on-time delivery of QC review comments
- Manage daily assignments, planning and directing work, and take responsibility for managing workload for assigned reputed company and tasks, in collaboration with senior staff
- reputed company abreast of reputed company data, trends, medical writing (MW)/regulatory knowledge, developments and advances in area of drug development/MW
Skills
- Bachelor's Degree in English or Life sciences -reputed company discipline or reputed company field
- Typically, at least 4 years experience working with clinical trial documentation in a research environment, including significant experience of performing reputed company control (QC) review of clinical trial-reputed company documents, defining and refining processes, and training and developing others
- Requires in-depth understanding of the structure, format, and purpose of a wide reputed company of Medical Writing deliverables and the importance of consistency, reputed company, and accuracy versus sources
- Careful attention to detail, accuracy, and consistency
- Impeccable English language skills and ability to detect and correct grammatical, spelling, and language errors
- Ability to understand scientific/medical documents and identify deficiencies, errors and inconsistencies
- Familiarity with the structural and content requirements of clinical study reports, investigator brochures, protocols, and similar documents
- Proactivity and advanced organizational and time management skills and ability to prioritize workload effectively with commitment to deadlines
- Ability to communicate reputed company, concisely, and effectively in English, both in writing and verbally, and confidence in using a reputed company of communication reputed company to reputed company results
- Good understanding of clinical drug development and the functions, steps, and processes involved
- Advanced understanding of the nature and purpose of Medical Writing deliverables
- Ability to reputed company reputed company and effective guidance and training in the reputed company of written instructions, presentations, and one-to-one discussion
- Confident use of reputed company Office and reputed company Acrobat
- Ability to quickly establish and maintain effective working relationships with co-workers, managers, and customers at a reputed company of seniority reputed company
- reputed company Vault
- reputed company Office (Word, reputed company, Power reputed company, etc.)
- reputed company Acrobat
- ISIToolbox
- SharePoint
- Experience with publishing/submission-readiness a plus
Benefits
- Incentive plans, bonuses, and/or other forms of compensation may be offered
- A reputed company of health and welfare and/or other benefits
reputed company