Manager – Quality Review – Ed-ICV
| Company | Bristol Myers Squibb |
|---|---|
| Location | Summit, NJ, USA, Princeton, NJ, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Minimum of BS/BA degree, preferably in the Life Sciences, with 10+ years of related experience OR MS/MA degree, preferably in the Life Sciences, with 8+ years of related experience
- Experience in performing quality review of key clinical and regulatory/submission documents
- Expertise in interpreting data from a broad range of scientific disciplines to enable critical scientific reviews for protocols and submission-related documents
- Understands pharmacokinetic (PK) and pharmacodynamic (PD) data and related terminology
- Specialized knowledge of editing and proofreading techniques for clinical and regulatory/submission documents
- Experience in developing QR standards, tools, and continuous improvement processes and delivering QR-related training to key stakeholders
- Requires minimal supervision and coaches/mentors new QR personnel and/or peers
- Advanced working knowledge of computer applications and other tools used to facilitate document reviews (eg, MS Office, PDF annotation tools), as well as documentation management systems
- Advanced knowledge of global pharmaceutical drug development process and ICH/GCP guidelines
- Able to manage timelines and quality of work while adhering to applicable SOPs/WPs
- Able to multi-task and prioritize independently; detail-oriented
- Excellent written and oral communication skills required
- Manages internal and external challenges effectively; seeks conflict resolution through negotiation
- Must possess strong interpersonal and communication skills, be a team player, and be willing and able to work in a fast-paced environment where evolving project priorities and timelines require flexibility
Responsibilities
- Performs scientific (content) and editorial (formatting) QR of ED-ICV and Clinical Pharmacology deliverables, ensuring: Good documentation principles (organization, clarity, completeness, scientific standards), Intra- and inter-document consistency, Data accuracy against referenced source documents
- Communicates QR observations to author(s)/stakeholders in a timely and effective manner
- Serves as a subject matter expert on QR standards, tools, and processes, including representation on continuous improvement workstreams as appropriate
- Active participation in select Departmental initiatives and process creation / revision / rollout
- Supports onboarding, training, and/or mentoring of new QR personnel and/or peers, including but not limited to liaising with CRO personnel who may be performing QR on behalf of BMS
- Supports the oversight of outsourced (eg, CRO) QR activities, as appropriate, to help ensure standards are being maintained and high-quality deliverables are being provided to BMS
- Provides instruction and guidance on templates, formatting and publishing to CROs, as applicable
- Represents ED-ICV QR function in various Organizational meetings including those pertaining to registrational activities, when necessary
- Provides input regarding metrics and other pertinent data summaries that are used by Leadership to objectify the QR Function’s performance, future resource needs, etc
Preferred Qualifications
-
No preferred qualifications provided.