Job Description

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 469,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives.
 
Visit us at www.accenture.com
 
People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.
 
The Regulatory Affairs Associate Manager-Labeling, Advertising & Promotional Materials is responsible for the content and compliance review of Labeling, Advertising and Promotional Materials, setting regulatory strategy and leading cross-functional, multidisciplinary teams, and executes client project initiatives. Envisions the future by using labeling strategy, advertising and promotional materials marketplace, technology and business knowledge. Collects and analyzes issues and trends that affect our client businesses. Possesses and leverages broad industry knowledge.
 
Job Description:
 
The Regulatory Affairs Associate Manager- Labeling, Advertising & Promotional Materials is a tactical and strategic role within Global Regulatory Affairs and Regulatory Operations functions at Accenture Applied Life Science Solutions (ALSS) located in Berwyn, PA.
The Associate Manager is generally responsible for the content and compliance review of labeling documents in support of client regulatory submissions, managing packaging insert, artwork, tracking labeling implementation, reviewing structured product labeling and drug listing submissions, and creating labeling sections of routine reports (PADER, Annual Report). They will support the regulatory strategy teams in scheduling and managing client labeling, advertising and promotional material reviews for products containing small molecules, biologics and medical devices encompassing several therapeutic areas.
 
Competencies for Labeling Projects:
 
Labeling Content Development and Review: 
  • Manages the content and reviews the processes for regulatory submissions
  • Labeling Supplements, Annual Reportable changes
  • Supports client labeling submission documents word, pdf, and reviews artwork files for Structured Product Labeling submissions
Labeling Implementation:
  • Manages implementation of new and revised labeling for regulatory submissions
  • Creates and reviews client mark-up labeling documents and artwork requests, works with client management team to create and approve labeling components and tracks implementation activities
  • Reviews and approves labeling components and maintains current and historical labeling activity history files (SharePoint and EDMS-based)
  • Maintains the US Labeling Repository SharePoint site
Structured Product Labeling:
  • Interacts with SPL team at AALS who creates, updates and submits Structured Product Labeling (SPL) content of labeling and drug listing files for marketed products and regulatory applications
  • Ensures labeling content is accurate and compliant to drug listing data elements for marketed products
Periodic Reporting:
  • Completes labeling sections for periodic reporting (PADERs and Annual Reports)
  • Supplies current labeling components for reports
  • Supports process improvements within the labeling function
 
Competencies for Advertising and Promotional Materials Review Projects:
  • Represents ALSS as Regulatory Affairs Consultant on the client projects concerning Promotional Review Committee (PRC)
  • Actively participates in review of advertising and promotional materials applying regulatory and therapeutic area knowledge to develop solutions to complex US promotional issues
  • Functions as Promotional Review Committee (PRC) representative for client assigned indications and ensures compliant, a thorough and efficient review of promotional materials
  • Provides assessment of risks for marketing, medical campaigns and plans for client projects
  • Maintains and evaluates productivity metrics and conducts reviews and approvals of Advertising and Promotional materials and provides comments to review teams
  • Maintains effective communication with key Clinical, Marketing, Regulatory, Legal and Medical Affairs counterparts and assists our clients in obtaining alignment among key stakeholders for issues

 


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Qualifications

 
Basic Qualifications:
  • Bachelor's degree
  • Minimum of 4 years of experience with regulatory labeling, advertising and promotional materials development and review within pharmaceutical industry
 
Preferred Skills:
  • Graduate in science, Regulatory Affairs and/or Drug Development
  • Experience with preparation of regulatory submissions
  • Increasing level of responsibility and experience in drug product labeling, strategy, and submissions
  • Knowledge/understanding of the regulatory application process, preferably with submissions experience
  • Working knowledge of the drug product development process, FDA regulations, directives and guidance for drug product labeling, advertising and promotional materials
  • Able to work independently researching regulatory intelligence information and making assessment of relevance of regulatory information on the issue at hand
  • Able to independently determine required documentation for regulatory submissions
  • Strong foundation of communication and negotiation skills
  • Experience with effective communication with the clients’ technologists, at various levels of the organization, and be able to clearly present ideas and arguments
 
Functional Knowledge:
 
Company/Industry Related Knowledge:
  • Working knowledge of the drug product development process, FDA regulations, directives and guidance for drug product labeling, advertising and promotional materials Strong foundation of communication and negotiation skills
  • Able to independently determine required client documentation for regulatory submissions

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.

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

Accenture is a federal contractor and 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.

 

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.

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