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Employment

X-GEN Pharmaceuticals, Inc. continues to experience steady growth and this results in rewarding employment opportunities for candidates with the right skills. X-GEN Offers Pay and Benefits that Include: Vacation, Simple IRA, Professional Growth, Advancement and Health Insurance.

Equal Employment Opportunity Policy Statement

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Available Positions (3)

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Title: Project Manager
Reports to:  Manager of Project Management

FLSA:  Exempt

 

General Responsibilities:
Manage the product development project pipeline and assignment and prioritization or resources.  Assist in launching sales and marketing of new products and development of new business.

Essential Duties:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code Of Corporate Values
    and conforming to established performance expectations.
  • Manage the product development project pipeline and assignment and prioritization of resources
  • Assist in scale up to commercialization
  • Collaborate with sales and marketing to develop and launch strategy for new business
  • Assign resources to projects and project objectives and monitor progress
  • Develop project plans and facilitate resolution of all issues to reach project goals
  • Manage project budget to reach revenue, cost and profit targets
  • Manage and communicate ongoing changes in tasks, goals, or performance
  • Participate in client meetings, contract finalization and development of requirements specifications
  • Performs other related duties as assigned or directed

Basic Qualifications:

  • Skills:
    • Product Management
    • Project Management
    • Supplier Management
    • Budget Management
    • GMP Compliance
    • Data Analysis
  • Proficient reading, writing, grammar, and mathematics skills;
  • Proficient interpersonal relations and communication skills;
  • Moderate computer skills: including Microsoft Office, Go To Meeting, MS Project
  • Travel:  Up to 40%


Education/Experience:

  • Bachelor’s Degree in discipline related to Pharmaceutical (Chemistry, Biology, Pharmacology); Advanced degree desirable
  • Project Management professional (PMP) Certification preferred

 

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Title: Manager of Inside Sales
Reports to:  Director of Sales and Trade Relations

FLSA:  Exempt

 

General Responsibilities:

Overseeing outbound sales calls to targeted customer classes with the objective of acquiring new accounts, growing existing accounts, retaining existing accounts and gathering intel about accounts. Hiring, training and evaluating inside sales staff. Monitoring inside sales staff performance in order to ensure that goals are met. Communicating with cross-functional teams to develop procedures for increasing sales, reaching additional markets and promoting business.  Managing advertising or inside sales team, setting campaign objectives, evaluating performance, and facilitating training. Coordinating product research and development and evaluation of campaign results. Oversee all call campaigns, planning strategies, preparing budgets, and reviewing promotional materials.  Tracking and analyzing metrics and providing reports on performance. Developing call scripts and formulas to improve results. Resolving customer problems, complaints and inquiries.

Essential Duties:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code Of Corporate Values and
    conforming to established performance expectations.
  • Manages overall activity of the department and directly supervises assigned personnel as follows:
    • Assists in the selection of new personnel as appropriate;
    • Makes provisions for the proper orientation and training of new personnel;
    • Reviews employee performance on a regularly scheduled basis;
    • Develops recommendations for employee career planning and development and oversees process for individual skills assessment and continuing education plans;
    • Coaches and directs personnel to ensure compliance with departmental goals, objectives and budgets;
    • Conducts regular meetings and provides guidance and direction to personnel;
    • Reviews employee’s time records, makes any necessary corrections, obtains appropriate signatures and submits for payroll processing;
    • Organizes, schedules, prioritizes and distributes workload among assigned personnel;
    • Keeps personnel informed of pertinent policies and procedures affecting the department and/or their jobs; Creates an atmosphere in which upward communication from employees is encouraged;
    • Administers personnel policies and procedures as established by company policy;
  • Manages cost center expenses as follows:
    • Constructs budget within prescribed guidelines;
    • Manages expenses to stay within budget; requests and approves payments depending on level of authority;
    • Reviews expenses on a regular basis to ensure proper recording of account expenses;
    • Explains variances, exceptions and other impacts that occur between budget and actual expenses;
    • Administers personnel policies and procedures as established by company
  • Track and analyze metrics, and provide reports on performance.
  • Develop call scripts and formulas to improve results.
  • Train and manage Inside-sales team with the aim to improve performance over time.
  • Assist in creating incentive program.
  • Campaign Management with pre and post analytics.
  • Increase Quantity & Quality of calls.
  • Performs other related duties as assigned or directed

Basic Qualifications:

  • Skills:
    • Campaign Planning
    • Call Center Support
    • Product Marketing
    • Lead Generation
    • Outbound Calling
    • CRM
  • Proficient reading, writing, grammar, and mathematics skills;
  • Proficient interpersonal relations and communication skills;
  • Proficient computer skills: including Microsoft Office, Go To Meeting, etc.
  • Travel:  Minimal

Education/Experience:

  • Bachelor’s degree in a business related discipline
  • A minimum of 5 years experience

 

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Title: Director of Regulatory Affairs
Reports to:  Vice President Enterprise Operations and Governance


FLSA:  Exempt

 

General Responsibilities:

Advise the company on the regulatory aspects and climate that would affect proposed activities.  Serve as primary point of contact for all regulatory ANDA submissions and subsequent supporting activities.  Provide appropriate communication and guidance to management and other internal functional areas responsible for submitting required regulatory documentation.  Develops the company’s regulatory strategy

Essential Duties:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code Of Corporate Values and conforming to established performance expectations.
  • Manages overall activity of the department and directly supervises assigned personnel
  • Manages cost center budget and expenses.
  • Ensures accuracy and approves filings of regulatory reports.  Ensures the daily execution of regulatory systems
  • Directs the development of internal regulatory policies and coordination of activities in collaboration with other enterprise resources.
  • Monitors internal practices and external requirements to ensure all of the organization’s operations remain in compliance with government regulations and guidelines.
  • Works with regulatory agencies to resolve concerns that may arise.
  • Maintains strong working knowledge of all regulations and laws relevant to the Regulatory function.
  • Develops and maintains relationships with key individuals within the FDA and internal and external X-GEN Partners to facilitate submissions.
  • Responsible for responding to regulatory inspection observations and filing deficiencies.
  • Assures that necessary Corrective and Preventive Actions are documented and implemented.
  • Works in partnership with Quality to ensures that the necessary documents are present, complete and accurate prior to submission of filings.
  • Performs other related duties as assigned or directed.

Basic Qualifications:

  • Skills:
    • FDA filing procedures
    • Regulatory Compliance
    • Experience with regulatory submissions in eCTD format
    • Total Quality Management (TQM)
    • Knowledge of and experience with Domestic and International Pharmaceutical Regulations and Guidelines
    • Demonstrated supervisory and leadership skills
  • Proficient reading, writing, grammar, and mathematics skills;
  • Proficient interpersonal relations and communication skills;
  • Proficient computer skills: including Microsoft Office
  • Travel:  Up to 15%

Education/Experience:

  • Bachelor’s Degree in Science (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent)
  • 15 years minimum experience in a Regulatory environment and 20 years within the Pharmaceutical industry.

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Application Procedure Candidates:

For consideration, please submit an electronic cover letter and resume, along with salary requirement, on our website. (careers@x-gen.us)  Resumes and cover letters will be accepted until the position is filled.

Thank you for your interest in the Project Manager position at X-Gen Pharmaceuticals.

X-GEN Pharmaceuticals is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people.  EOE/AA.Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet

If you would like to submit a resume for future consideration, please use the form below.

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