Dossier Specialist (Nonclinical Submissions)
Share
Job Location:
Spring House, PA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
- Read understand and follow through on all correspondences with the ability to work independently as well as participate within cross-functional teams including global interactions in different time zones.
- Prepare finalize and process all nonclinical research reports for electronic submission (eSub)-readiness in applicable document management systems:
- Internal and CRO study reports
- All nonclinical sub-areas and clinical bioanalysis
- Client-owned and purchased/co-developed products
- Ensure that all assignments comply with the internal and regulatory standards.
- Interact with all levels of the organization to meet submission timelines.
- Support the various Therapeutic Areas with a focus on eSub-readiness of reports and submission documents.
- Draft and update Content Plans Advanced Component Reports and the Study Tagging Files to supplement the dossier plan for submissions.
- Help Study Directors NCS leaders etc. to find documents in applicable document management system(s).
- Support and coach all users of applicable document management system within PSTS.
Qualifications :
Minimum Qualifications
- A minimum of an associates degree with 5 years Pharma experience or a bachelors degree with at least 3 years Pharma experience
- Hands-on experience with Document Management Systems (DMS): locating/routing documents user support account requests and basic administration.
- Proven experience in preparing finalizing and processing nonclinical study reports (internal and CRO) and submission documents.
- Familiarity with eSubmission concepts (Content Plan/Advanced Component Report Study Tagging Files) and electronic submission
- Advanced Microsoft Word skills (templates styles bookmarking hyperlinks) and experience with Acrobat/PDF publishing.
- Experience performing technical QC of documents and ensuring alignment with internal/regulatory format standards.
- Must have strong interpersonal skills including effective listening as well as clear oral and written communication provide technical mentorship to authors in providing e-submission ready documents.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
Additional Information :
Position is Full Time Mon-Fri 8am-5pm with overtime as needed. Candidates currently living within a commutable distance of Spring House PA are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage dental and vision options.
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
