GRA Publishing Specialist (Regulatory Affairs)

Our plans for tomorrow are as bold as yours. Schering-Plough has new drugs on the horizon, new partnerships and a renewed dedication to leadership, values and hard work - the same qualities that made us an industry leader for decades. Each day, we grow our relationships and establish the trust of doctors and patients alike, while providing them with a steady flow of the most innovative and effective science-based medicines and services.



As we strive to achieve these goals, our commitment to building a diverse, global, highly skilled workforce has become even stronger, with performance driven incentives, leading edge training and development, and excellent opportunities for professional advancement. We are building a new and special kind of healthcare company. The change, the excitement, the opportunity are infectious.




GRA Publishing Specialist (Regulatory Affairs)

Requisition Number: 15573BR


The successful candidate will facilitate the compilation of electronic submissions to international health authorities.

Specific Duties Include:

Prepare electronic submissions to the FDA and Schering Subsidiaries according to electronic guidance's from FDA, EMEA and ICH.
Provide advanced publishing services including: Apply submission formatting, electronically publish complex documents and submissions in CoreDossier, Acrobat and Compose.
Provide Document Management services including electronic document secure storage in the submissions document repository as well as tracking and logging incoming electronic documents
Perform electronic/hardcopy verification
Prepare/participate in the revision process for submission document templates
Assist with validation testing
Participate in the SOP creation/approval process

Education:
Bachelors degree and 1-2 years Pharmaceutical experience or equivalent 5 years experience and a minimum of 1-2 years Submissions experience

Skills:
Strong organizational, interpersonal, written/oral communication and word-processing skills
Proficient in electronic document publishing, scanning, electronic document management and Adobe Acrobat. CoreDossier and Documentum experience a plus.

To apply, email your resume and cover letter to: John.Memmel@spcorp.com

Visit us at: www.schering-plough.com/careers We value the diversity of our global workforce. We are an equal opportunity employer.



As part of the Schering-Plough team, you?ll benefit from strong leadership, a new vision and an empowering corporate culture while enjoying competitive compensation and a progressive benefits package.


Schering-Plough is an Equal Opportunity Employer.