Regulatory Labeling Associate Role in Lawrenceville, NJ

Position Summary / Objective

The RIM Labeling Contractor is accountable to enter and manage regulatory information in the authoritative system. Specifically this individual will enter global labeling revisions of the Company Core Data Sheets (CCDS) for commercial products. Notifications of these regulatory changes are sent via a RIM workflow to country regulatory managers who assess it against the current local label and plan submissions. The RIM contractor will monitor data quality, accuracy, and ensure country-level data is available in a complete, and timely manner. Create reports/metrics to identify issues and analyze data trends. Function as a strong RIM user, interact with country regulatory associates, address questions and solve problems. Utilizing training on other regulatory processes, this associate will also support ad-hoc RIM requests. Participate in system testing for upgrades by executing scripts and being involved in validation.

Position Responsibilities
• Functions as a process expert for labeling submissions and CCDS updates in the RIM system.
• As a detail-oriented worker, manage daily workload independently understanding the business goals.
• Runs data quality reports to check process compliance on local assessments. Inform country managers of issues. Arrange meetings as needed to advise them on use of
the system and resolve the problems.
• Update data quality trackers and escalate issues when necessary.
• Use Excel to summarize information for inclusion in Power Point presentations provided to management.
• Contributes to and helps identify system and process gaps in labeling. Develop new RIM reports and dashboards.
• Provides support for internal audits, HA inspections and may be asked to contribute to the resolution of corrective preventive action plans.
• Executes operational tasks according to RIM procedures and work instructions.

Degree Requirements - BS/BA in a relevant scientific or technical field preferred

Experience Requirements
• Minimum of 3 – 5 years of relevant experience

Key Competency Requirements
• Demonstrates critical thinking skills and the ability to apply this to daily workload decisions
• Demonstrates awareness of the procedures and decision-making process of government Health Authorities and how it relates to RIM
• Strong understanding of regulatory operations
• Knowledge of computer systems in an R&D environment. Firm knowledge and experience with eCTD, SPL and submission standards. Ability to navigate marketing application submissions structure and content. Basic understanding of electronic records management rules
• Participates in projects and communicates and interacts with internal and external customers
• Practical experience with desktop application software suites
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. Good presentation skills.
 
Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to Axelon.  I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market.

If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices.

Contact
Shashikanth Bandapally
Recruiter
Axelon Services Corporation
44 Wall Street 18th Floor
New York, NY 10005
Phone: (212) 488-7460
Fax  : (212) 306-0191
Shashikanth.Bandapally@axelon.com

Clinical Project Coordinator - New Brunswick, NJ

 W2 contract only, please call me to discuss the rate***

Manages multiple projects in the clinical packaging and labeling group. Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects. Works cross-functionally with individuals and project teams in various areas. Identifies and reports issues to appropriate levels of management in a timely manner. Manages clinical label text for assigned projects in including proof creation, management, manufacture, and approval. Reviews and approves vendor generated label proofs and other related documents. Generates packaging and labeling production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement. Authors and/or reviews procedural documents.

BS degree in Natural Science or related field is required
 
Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to Axelon.  I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market.

If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices.

Thank you,

Sahnaj Pervin
Phone: (212) 488-7719
Recruiter
Axelon Services Corporation
44 Wall Street 18th Floor
New York, NY 10005
sahnaj.pervin@axelon.com

Digital Marketing Operations Manager Role - Lawrence Township NJ

 Job Description:

Business Function GENERAL MANAGEMENT
Department Name Worldwide Production Management and Content Creation
Reporting Business Unit Name WORLDWIDE Engagement Planning & Content Capabilities

The Production Manager (Producer) will be a critical matrix team partner for the Product and Engagement Planning teams, seeking to create a versatile role for marketing campaign management and execution across Digital and Print materials for a Brand book of work or a particular therapeutic area or franchise. The Producer Role is responsible for gathering estimates on production work efforts across tactics, based on established brand and engagement strategy plans for the upcoming year, ensures tactical campaigns aligned with the strategy are carried through and executed in the proper cadence, fed by content module approval and tactical activity calendar updates.

Key Responsibilities
• Obtains Production estimates for a book of work for a series of brands or Therapeutic area – provides the Production Management Lead with ongoing financial reporting across production/execution, reconciles on monthly basis.
• Cross-collaborates on the content planning timing in order to execute required campaigns
• Collaborates with Capability Leads, IT and Engagement Planner to schedule resources and plan executions
• Tracks 8 stages of cycle of campaigns and coordinates across the matrix to meet deadlines where timing may be challenged
• Is aware of KPIs and is informed of campaign analytics with Business Intelligence & Analytics to help assess content performance to prepare for course corrections and enhancements
• Performs QA and spot checking across materials for both digital and print
• Runs or attends status meetings for Brand or Therapeutic area with matrix participants
• Will learn Tools used to support project management, workflow, timelines, finances, etc. and inform improvements needed and in some cases lead a project with IT.

Education & Experience Requirements:
• Bachelor’s degree
• Campaign marketing
• 3+ years in marketing and/or activation in large complex organization
• 2+ years of Print and Digital marketing management planning and budget allocation experience
• 2+ years Project Management experience (PMP not required, but ideal)
• Strong PM skills and digital execution
• Familiarity with Agile Principles
• Understanding marketing data performance and how it informs decision-making
• Familiar with marketing asset specifications, templates, content management systems, workflows
• Highly organized and detailed oriented, accustomed to fast-paced settings
• Exceptional written and verbal communication skills, with demonstrated ability to write, collaborate on and edit communications and presentations where needed
• Has passion for the role, shares ideas, brings improvements forward, teaches others
• Experience managing external vendors, budgets and invoicing including vendor performance management
• P&L or knowledge of Budget Management required
• Excellent verbal and written communication skills are required
• Experience with all pharma marketing and launch scenarios, a plus
 
Note: Please allow me to reiterate that I chose to contact you either because your resume had been posted to one of the internet job sites to which we subscribe, or you had previously submitted your resume to Axelon.  I assumed that you are either looking for a new employment opportunity, or you are interested in investigating the current job market.

If you are not currently seeking employment, or if you would prefer I contact you at some later date, please indicate your date of availability so that I may honor your request. In any event, I respectfully recommend you continue to avail yourself to the employment options and job market information we provide with our e-mail notices.

Thank you,
Abdul Shaik
Recruiter
Axelon Services Corporation
44 Wall Street 18th Floor
New York, NY 10005
Phone: (212) 488-7704
Fax  : (212) 306-0191
abdul.shaik@axelon.com