Senior Associate, Regulatory Document Publishing

Location
Basking Ridge, New Jersey, United States
Posted
Aug 24, 2020
Ref
10127BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

Position assists in the planning, preparation and delivery of electronic documents for regulatory submission of investigational and marketed products worldwide. This position requires knowledge on US and EU standards for regulatory submissions, confirming that DS documents meet those standards. It also requires supporting the preparation of all regulatory document components to ensure they are available to meet the global submissions timelines.

The Senior Associate is expected to assist in the document preparation work of internal and external vendors for dossiers. This includes allocating work to internal and external contractors, ensuring that the work allocated to those contractors is delivered in a timely manner and that the work done is compliant with DS and regulatory authority submission standards. This may involve communicating the DS standards to the internal DS personnel and to contractors/vendors. It also involves QCing the work of internal, external, and outside vendors.

This position assists on document strategy and conducts checks of accuracy and consistency of documents intended for submissions. This position demonstrates expert document formatting knowledge, advanced planning experience, and the understanding of electronic document management practices

The Senior Associate is also expected to familiarize themselves with the preparation and use of Clinical Regulatory documents This position is expected create and review the cross-links across vaults, extract documents from the eTMF Vault and use them to create CSR appendices.

The Senior Associate is expected to work with the Manager Regulatory Operations to develop more efficient and speedy work processes across functional areas that also ensure that quality is built into the document preparation process.

Responsibilities:

Technology: Supports all document publishing programs, document templates and/or project planning applications. Supervises the identification, compilation, and assembly of required documentation for various clinical/regulatory documents. Advanced, tactical working knowledge of the changing Health Authority guidelines regarding document standards. Provides input on regulatory submission process improvements and the establishment of repeatable processes utilizing key technologies.

Process: Manages the evaluation of processes to ensure organizational responsibilities are met with the highest degree of quality and timeliness for regulatory and clinical documents.

People: Establishes and maintains effective timely communication across Regulatory Operations including Regulatory Affairs and Clinical Development Operations. Supports document tactical activities. Communicates and actively collaborates with managers concerning the document process; assists in creating, communicating, and implementing organizational goals and objectives. Assists in training personnel in regulatory document preparation, review, and publishing and planning activities ensuring compliance.

Document Excellence Team Leadership/Group Facilitation: Demonstrates an expert understanding of document preparation process and role of each contributing discipline. Attends the document preparation team meetings. Maintain document planning issues log with document planning responsibilities.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

BA/BS in relevant discipline desired (or equivalent years' experience)

3-5 years industry experience (preferably in, Regulatory Operations/Regulatory Affairs)

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Job Title
Senior Associate, Regulatory Document Publishing

City
Basking Ridge

Functional Area
Regulatory Management Operations

State
New Jersey