Global Medical Affairs Operations Specialist

Location
Emeryville, CA, United States
Posted
Aug 31, 2018
Ref
olaa8fwx
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION

Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 3,500 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people and will grow by 50%+ in the near future.

With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.

We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.

We are in search of top talent to help us meet our aggressive and important goals.

PRIMARY PURPOSE OF POSITION

The primary purpose of this position is to support Global Medical Affairs (GMA) with implementation, maintenance and oversight of systems, technology and processes. The Operations Specialist develops and maintains smooth, efficient function of system and resource solutions to meet departmental tracking and compliance needs. The Operations Specialist consistently applies a clear understanding of Medical Affairs current best practices and regulatory requirements to ensure system and process compliance. The Operations Specialist also administers library services for Santen Inc., oversees contract administration, liaises with clinical trial investigators, manages database updates, writes system operation manuals and other relevant documents, assists with system training, runs projects and meetings, and contributes to departmental budget tracking and data analysis.

MAJOR DUTIES OF POSITION:
  • Serve as one of several system administrators for multiple GMA systems
  • Manage multiple projects and assignments in a fast-paced environment, including system upgrades, batch record or document uploads, data entry QA/QC, spreadsheet updates and formatting, etc.
  • Execute validation and other test scripts as needed; participate in and/or organize UAT sessions
  • Manage requests and implementation of user account creation/deactivation, reset passwords, etc.
  • Perform periodic audits of GMA systems
  • Author system operations guides, user manuals, and other reference documents
  • Manage vendors providing systems or digital services
  • Assist with budget modeling, forecasting and tracking; invoice tracking and processing
  • Liaise with study sites, investigators, legal and financial contacts from IST initial approval to study closure, including contract administration, facilitation of protocol review, supply chain liaison, database maintenance, milestone payment tracking, drafting study correspondence
  • Coordinate review and approval meetings for IST proposals
  • Maintain IST-related study files; collect and maintain regulatory documentation
  • Assist with contracting processes for GMA systems
  • Manage the library and subscription services for Santen Inc. with minimum supervision
  • Assist with organizing training for GMA systems, processes and scientific sessions on a global and regional basis
  • Assist with training file organization and documentation
  • Assist with data analytics, including BI dashboard development and working with end users to maximize dashboard utility
  • Work to ensure key system and team performance indicators are met
  • Communicate project or meeting outcomes in a timely and clear manner to various stakeholders in the organization; record meeting minutes
  • Stay up-to-date on Medical Affairs best practices and current trends in regulatory compliance for systems, processes and ISTs
  • Stay current on basic scientific and clinical trial knowledge for Santen's innovative product portfolio
  • Assist with other Medical Affairs duties as needed and additional responsibilities as assigned by management

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Minimum: Bachelor's Degree in a scientific field required
  • Minimum 3+ years of previous pharmaceutical or scientific industry experience; previous experience supporting a Global Medical Affairs organization preferred
  • Proven track record of multi-tasking and administering multiple systems or projects in a complex business environment; ability to prioritize
  • Minimum 3+ years managing and administering databases required. Knowledge of IRMS, Veeva, EnvisionPharma systems a plus
  • Strong computer skills required, including advanced Microsoft Office Suite (Word, PowerPoint, Visio and Excel) and other applications. Strong computer graphic skills are a plus
  • Business analytics experience is a plus, especially with Tableau and/or PowerBI
  • Experience managing vendors, especially for systems/technology work
  • Proven ability to interact with employees at all organizational levels in a culturally diverse work environment; previous experience working in a global matrix organization strongly preferred
  • Proven ability to build strong working relationships with internal cross-functional colleagues as well as external medical professionals
  • Strong written and verbal communication skills; public speaking and presentation skills
  • Excellent attention to detail and organizational skills required
  • Advanced project management and process improvement skills; project management certification a plus
  • Familiarity with clinical trial management preferred
  • Familiarity with library or subscription services management preferred
  • Able to work from local corporate office based in Emeryville, CA
#LITA1

For more information about our company and the work experience, please visit www.santenusa.com