Regulatory Document Specialist (m/f)

Job description

Job Description

• Support internal and external customers and promote best documentation practice to ensure efficient an appropriate management of submission-relevant clinical documentation to meet regulatory requirements for submission to Health Authorities and be inspection ready.
• Ensure technical quality standards of clinical documents for the use in Regulatory Submissions by:
a. Managing, tracking and keeping oversight over Technical Document Quality Check requests from global Business Functions.
b. Conducting Quality Checks as well as managing Quality Checks conducted by an external partner. Collaborate with external partner’s regional coordinators on daily operational activities and monitor/assess appropriate hand-offs by vendors.
• Define document management strategy for template management and overall technical compliance for clinical submission documents. Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs.
• Ensure adherence to Document Management standards across Business Units by acting as first line contact for Business Users of Document Management Systems and Processes.
• Assist in driving improvements and innovation on all business and technical aspects of clinical document management, including implementation of innovative methods.
• Establish and maintain sound working relationships with internal and external partners/business functions and customers.
Position Title

Regulatory Document Specialist (m/f)

Desired profile

Minimum requirements

• College degree or equivalent education or job experience in life science/healthcare or related scientific discipline (natural, pharmaceutical, medical, archival or information technology).
• Fluent English (oral and written) preferred.
• At least 2 years of relevant experiences in managing, archiving, retrieving or compiling submission documents
• At least 2 years of relevant clinical research/pharmaceutical industry experiences
• Knowledge of the clinical drug development and international drug approval processes and related document requirements
• Ability to work in a cross-cultural, virtual environment.
• Good IT skills (minimum MS Word and Adobe PDF)
Job Type

Full Time
Country

Germany
Work Location

Holzkirchen (near Munich)
Functional Area

Research & Development
Division

Global Drug Development
Business Unit

GDO GDD
Employment Type

Regular
Company/Legal Entity

Hexal AG