Record Information Analyst (Cambrdige, MA)
Responsible for management and oversight of local and global Regulatory records and documentation, both in paper and electronic format. This role is responsible for information migration activities to support acquisitions and/or divestiture. In addition support is required for labelling uploads and litigation and submission related activities. The IM Support may support GRA special initiatives, validation and testing of new and upgraded software that impacts information management and retrieval, eg. EDMS and RIM systems/tools.
- Managing Regulatory's local and global archives-offsite and on-site creating clear records and ensuring ease of retrieval.
- Maintaining records retention information pertaining to paper archives and managing lifecycle of documentation, including arranging destruction following company's policies and procedures.
- Supporting Records Manager to actively manage Information migration activities to support acquisitions and/or divestitures.
- Receive and process documentation of company's approved labelling, ensuring the information is stored, maintained and accessible.
- Maintain effective relationships across GRA, R&D ensuring that information managment needs are met and requests for information are handled in a timely fashion.
- Support for special projects and integration activites.
- Contribute to new and updated process and standards.
Education and Skills
- Bachelors degree or related experience is required
- Min. of 3+years' experience in a R&D environment or (6+ years without Bachelor degree), of which:
- Min 3+years experience in an information management environment
- Min. of 3 years of experience in electronic document management
- Experience in the preparation and submission of documents using regulatory/document management systems (ie. Documentum, First Docs, eCTDXpress, Validation tools) is highly preferred
Knowledge & Skills
- Global experience is strongly desired.
- Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
- Excellent analytical and communication skills both verbal and written.
- A self-starter, who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach.
- Ability to work on projects and timelines in a matrix team environment.
- Strong attention to detail and accuracy is a must.
- Ability to effectively present information to management, staff and other departments.
- Ability to cultivate internal and external relationships based on trust and respect in anticipation
- of future working relationships
- Demonstrated ability to proactively maximize relationships to enable successful collaboration
- Demonstrated ability to facilitate a beneficial resolution of conflict
- Demonstrated ability to work co-operatively within and outside the organization to accomplish the best outcomes for company's ability to work in diverse teams to optimize decision-making.
- Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
- Strong working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
- Strong interpersonal and organizational skills.
- Technical and problem solving skills, with an ability to understand and translate business issues and requirements.
Sthree US is acting as an Employment Business in relation to this vacancy.