Job Description

Join Accenture and help transform leading organizations and communities around the world. The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. Choose Accenture, and make delivering innovative work part of your extraordinary career.

 

The StartingPoint (Regulatory Submission Authoring Technology Product) Support Lead role resides within Accenture's Applied Life Sciences Solutions (ALSS) business service. ALSS helps clients make a meaningful impact on patients’ lives by combining new science with leading-edge technology. We’re working with our clients to revolutionize how medical treatments are discovered, developed and delivered.  Professionals who work on the StartingPoint Product team within ALSS are focused on improving the submission authoring process and eSubmission-readiness for customers who will be submitting drug applications to health authorities worldwide. 

 

Job Description

 

The StartingPoint Product Support Lead will be the primary customer support contact for the StartingPoint authoring suite and responsible for providing technical guidance and eSubmission readiness support for all authors contributing content to regulatory submissions.  Under the direction of the StartingPoint Product Manager, the Support Lead is responsible for managing the daily tasks associated with the product support queue including troubleshooting customer issues, providing them with solutions, and escalating issues to senior staff when appropriate, as well as daily communication with clients.  Additionally, the Support Lead will assist with product sales support (demonstrations), offering strategy, product upgrades and validation testing, template customizations, and submission document reformatting projects as needed.  The Support Lead would also provide product and eSubmission readiness training to sponsors.

 

Reporting directly to the Software Product Manager, the StartingPoint Product Support Lead’s primary responsibilities will include the following:

• Handle customer queries in a timely and professional manner

• Receive the support email or call, and provide initial response to the customer, gathering information as needed

• Troubleshoot customer issues, and respond with a resolution or escalate the issue as needed to Product Management

• Keep accurate records and track customer support issue and resolution

• Prepare and manage software upgrades to existing customers

• Assist with software validation for new releases

• Manage customer contact information and customer download sites

• Assist with customer sales support and demonstrations of tool

• Provide product and eSubmission readiness training to sponsors

• Assist with customer-specific template customizations and reformatting services when needed

• Assist with formatting submission templates and managing updates coming from Regulatory Affairs

• Assist with customer invoicing, accounts receivables as needed

• Regularly communicate with clients, including, but not limited to, face to face meetings, presentations, telephone, email, and conference call interaction


Accenture Carnival

Carnival Corporation reimagines guest experiences with high-touch tech.
Read More

Qualifications

Basic Qualifications:

• Strong Microsoft Word skills, including working with Microsoft Word Styles

• Experience with rendering documents using Adobe Acrobat and working with bookmarks or other PDF rendering software

• Demonstrated ability to think strategically and troubleshoot complex technical issues

• Bachelor’s degree

• Ability to travel 20%

 

Preferred Qualifications:

• 1+ years’ experience in Regulatory Operations, Affairs, or Regulatory Systems IT

• Experience with publishing software and/or electronic document management systems and other tools used throughout the Pharmaceutical industry

• A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)

• Experience with authoring systems and processes, including the use of Style Guides.

 

Important information

Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture.

Accenture is an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.

Equal Employment Opportunity

All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

Accenture is committed to providing veteran employment opportunities to our service men and women.

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

 

Accenture is an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.

Equal Employment Opportunity
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

Accenture is committed to providing veteran employment opportunities to our service men and women.

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

Life at Accenture

Work where you're inspired to explore your passions and where your talents are nurtured and cultivated. Innovate with leading-edge technologies on some of the coolest projects you can imagine.

image

Training and Development

Take time away to learn and learn all the time in our regional learning hubs, connected classrooms, online courses and learning boards.

LEARN MORE

image

Work Environment

Be your best every day in a work environment that helps drive innovation in everything you do.


LEARN MORE

View All

Learn more about Accenture

With over 450,000 employees in more than 120 countries, Accenture solves our clients' toughest challenges by providing a broad range of services and solutions in strategy, consulting, digital, technology and operations.

View All

Stay connected

Join our Team

Join Our Team

Search open positions that match your skills and interest. We look for passionate, curious, creative and solution-driven team players.

Keep up to date

Keep Up to Date

Stay ahead with careers tips, insider perspectives, and industry-leading insights you can put to use today–all from the people who work here.

Stay Connected

Stay Connected

Receive job alerts, latest news and insider tips tailored to your preferences. See what exciting and rewarding opportunities await.

View All