This job is in in Southern California, but relocation assistance is offered.
Responsible for writing and editing key Global Safety and Epidemiology (GS&E) documents for global regulatory submissions, including Periodic Safety Update Reports (PSURs), Risk Management documents (RMPs and/or REMs), post-marketing sections of NDA/MAA/INDs, and post-approval regulatory commitments as needed. Will work primarily with Global Safety Scientists, Global Safety Officers, and Epidemiologists to coordinate, prepare, review and format GS&E documents and reports with well organized and effectively summarized safety information, with high quality and within predetermined timelines. The Professional will support consolidation of Team/Reviewer comments and questions and conduct data quality checks as needed.
This is a position involving multi-disciplinary interaction within the various functional groups of GS&E as well as outside contributing departments, including Regulatory Affairs, R&D Clinical Development, Medical Affairs, Marketing, and on occasion Senior Management, Therapeutic Area Leads, and the Chief Medical Officer.
The Professional is responsible for tracking progress of assignments and for assisting with multiple ongoing projects. Helps implement new/modified departmental processes (SOPs, WIs, templates and forms, etc), and must operate with minimal supervision. Serve on cross-functional committees and teams, as applicable. Excellent oral and written communication skills are required, with a strong knowledge of, and experience in interpreting and applying, global pharmacovigilance and risk management regulations and guidelines.
· Assist GS&E staff in authoring draft and final documents, applying scientific assessment to content, and completing according to predetermined timelines. Work with GS&E colleagues and contributing stakeholders to consolidate and address feedback/questions arising from Team Review of documents.
· Support Quality checks of safety data and information as applicable to ensure accuracy and high quality documents. Perform technical QC for published submissions as needed.
· Keep up-to-date knowledge of regulatory document requirements and assure documents meet Regulatory requirements as well as departmental standards for formatting, consistency, and adherence to company Styles. Apply a solid understanding of content and formatting requirements for PSURs, RMPs/REMs and post-marketing sections of regulatory filings (NDA, MAA, IND). Work with GS&E staff to produce/update Common Technical Documents (CTD) templates and other templates as needed.
· Attendance at team meetings or cross-functional committees
· Supports GS&E in maintaining tracking system for safety related documents/deliverables, and assists with document archival in electronic document management systems.
Education and Experience
· An advanced degree (or equivalent experience) in health care, or other suitable combination of education and 5+ years of specific experience.
· Experience preparing PSURs, RMPs/REMs, and other post marketing safety reports for regulatory agency submission
· Understanding of EU and US Pharmacovigilance, Risk Management, and post-marketing safety requirements
· Familiarity with medical terminology, and MedDRA
Essential Skills and Abilities
· Excellent planning, organization, and communication skills (written and oral).
· Ability to compose and review scientific documents for content, grammar and style, with high degree of attention to detail and in consideration of stakeholder feedback.
· Assertive individual with a proven ability to work effectively and flexibly with others and with a team-oriented effort.
· Ability to track progress and manage multiple projects.
· Good understanding of requirements for post-marketing modules of the eCTD.
· Thorough knowledge of word processing and spread sheet programs (MS Word and Excel), Adobe Acrobat. Experience with electronic document management systems. Competency with automated data collection systems
P: 215-750-7500 F: 215-750-1398 C: 215-630-6848