Careers at ISPE

Do you want a career where you know you are MAKING A DIFFERENCE?

We select people with creativity, integrity, passion and the ambition to make a difference and we focus on attracting and choosing the brightest and best talent.

We’re looking for people who:

  • Have a STRONG work ethic – know how to work hard and set high goals and expectations for themselves
  • Are TEAM PLAYERS – collaborate efficiently and effectively and understand that no one can achieve greatness on their own
  • Maintain a POSITIVE ATTITUDE - even in difficult or stressful situations
  • Are LEADERS and can take charge and tackle projects, both big and small

Career Opportunities


Our Core Values

Core values are the fundamental beliefs upon which ISPE is based on. They are the guiding principles that we use to manage our business, our Members, and internal customers and should be the anchor for every facet of our organization.

accountability

ACCOUNTABILITY

We accept responsibility for our work and learn from our mistakes
We honor our commitments and will take personal responsibility to help achieve the desired results. We proactively work to overcome obstacles. We learn from our mistakes and use them as an opportunity for improvement.

collaboration

COLLABORATION

We work together to achieve our goals
We are a global team united by a common purpose as defined in the strategic plan. We encourage open communication, coordination, and team-based approaches to achieve goals.

professional excellence

PROFESSIONAL EXCELLENCE

We deliver quality work and are open to exploring and trying new things
We deliver quality work through our competence, commitment to continuous learning, and motivation to achieve the Society’s goals. We will be fearless in pursuing new approaches that help us achieve our goals. We embrace change for the opportunities it brings.

Integrity

INTEGRITY

We are honest, fair, and ethical
We conduct our business with the highest standards and professionalism. We are transparent, honest, and ethical in all our interactions with one another, our members, and others.

respect

RESPECT

We embrace diversity, provide support, and encourage one another
We recognize that diversity in thoughts, opinions, and backgrounds contributes to making us a stronger team. We approach one another with open minds and in a way that promotes positive interactions.


Benefits

We offer a generous and competitive benefit package, including medical, dental and vision coverage, holidays and other paid time off, retirement, life and disability insurance, and more.

Health Benefits

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance

Income Protection and Security Benefits

  • Life Insurance/AD&D
  • Dependent Life Insurance
  • Short-Term Disability
  • Long-Term Disability
  • Medical Flexible Spending Account (FSA)
  • Dependent Day Care Flexible Spending Account (FSA)

Work-Life Balance

  • Work from home opportunities available for some positions
  • Stress Management Program
  • Employee Assistance Program
  • Compassionate, Jury Duty and Military Family leave
  • Generous PTO plan including:
    • Closed from Christmas through New Year's Day
    • 9 Paid holidays
    • 3 Personal days
    • Opportunities to carry over PTO or cash it out at the end of year

Our vision is to be an association that serves our Members and patients by leading the scientific, technical, and regulatory advancements of the pharmaceutical and biopharmaceutical industry. Working together, we will accomplish this by initiating discussions, collaborations, education, and training on relevant issues that matter the most in the industry.

Our success is dependent on the commitment and competency of all who work at ISPE. See a list of open positions below. If you don’t see an open position below but are interested in a career at ISPE, please send your resume to our Sr. Director of Human Resources.

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Career Opportunities

  • Member Services Coordinator

    IMMEDIATE SUPERVISOR: Manager of Member Services

    DEPARTMENT: Member Services

    General Summary

    Looking for an individual with a demonstrated passion for excellence with respect to treating and caring for our members. Must have a highly developed sense of integrity and commitment to providing excellent customer experiences. This position is responsible for answering member questions and requests and resolving them in a timely manner, making outbound phone calls when necessary, processing dues, publications, conference, training and other payments, data entry and maintaining up-to-date membership information. Serves as the front-desk receptionist as assigned.

    Principal Duties and Responsibilities

    • Professionally handle incoming member requests timely and accurately.
    • Thoroughly and efficiently gather member information, access and fulfill member needs, educate the member where applicable to prevent the need for the future contacts and document interactions
    • Maintain a high level of knowledge and understanding about ISPE’s membership products and services.
    • Make a high volume of ongoing outbound calls for membership recruitment, retention and for other departments as needed, in a manner and with the goal of producing sales.
    • Triage membership and customer requests from inbound calls and emails within 48 hours.
    • Provide quality service and support in a variety of areas including, but not limited to: processing manual membership applications/renewals, publications, conference/ training registrations, billing/invoices, and system troubleshooting while using the the AMS (Association Management System) database.
    • Update and maintain Member records in the AMS and assist with any discrepancies.
    • Perform back-up duties to team members as assigned and for shipping/receiving as needed.
    • Run database queries and reports using Excel Query or Report Manager.
    • Create conference and training event records in the AMS.
    • Follow up on unpaid training or conference attendees, no-shows and transfers.
    • Process returned mail, tracking Members’ updated information as needed
    • Develop a complete understanding of batch control and data entry.
    • Cover front desk duties as assigned.
    • Display a high level of knowledge for web navigation and ability to research products and services.

    Education and work experience:

    • Must be able to type a minimum of 45 words a minute.
    • Two years of college or Association experience, or high school diploma and 4 years of office and/or customer service.

    Skills and knowledge:

    • Detail-oriented team player.
    • Experience with an AMS or CRM System.
    • Knowledge of Microsoft Word, Excel, PowerPoint and Outlook.
    • Knowledge of database and/or SQL a plus.
    • Able to multitask and handle high volume of work while remaining professional and courteous.
    • Proven accurate data entry skills.
    • Able to construct written emails in response to requests accurately, with excellent grammar and spelling.
    • Able to sit for long periods of time in front of a computer and lift 25-30 pounds.
    • Able to handle and resolve difficult customer service situations and remain professional and friendly.
    • Strong verbal and written communication and listening skills.
    • Must be able to work 8:30am to 5:30pm or 9:00am to 6:00pm, Monday thru Friday.
    • Must be able to work some overtime if necessary. Must have some flexibility with scheduling and may be required to travel with event staff.

    The above declarations are not intended to be an "all inclusive" list of duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are intended only to describe the general nature of the job, and are a reasonable representation of its activities.

  • Senior Director of Guidance Documents

    The Senior Director of Guidance Document Development is responsible for overseeing the development of ISPE’s well-respected collection of Guidance Documents and interfacing with ISPE’s knowledge networks including Communities of Practice (CoPs) and ad hoc groups formed from time to time to advance the organization’s strategic goals. Working across these areas of technical content, the Director identifies products for development as well as other opportunities, and manages projects to maximize ISPE’s results as measured by revenue, membership, and engagement. In this position, the Director works closely with the Guidance Documents Committee (GDC) to solicit proposals for Guidance Documents from the Society’s Knowledge Network Council (KNC) and Communities of Practice (CoPs); provides project management oversight to the document development teams during the manuscript creation process, and provides technical expertise and direction during the industry review and editing phases. The Director also works with the KNC and CoPs to create content for conferences, training, and other publications. The Director strives to ensure effective collaboration and alignment of objectives between these various groups, other ISPE departments/teams, and key external partners when appropriate.

    Principal Duties and Responsibilities

    Essential Functions

    • Lead strategic initiatives and meet objectives/metrics/timelines reflected in the ISPE annual business plan.
    • Serve as Staff Technical Lead to ISPE’s Guidance Documents Committee and any GDC subcommittees, providing technical insight and expertise during the document review process.
    • Provide project management oversight to the individual Guidance Document development teams, including identifying mentors on the GDC to work with them.
    • Work with the GDC to assess member needs and prioritize Guidance Document development efforts.
    • Manage the work of the Technical Writer/Editor(s), ensuring that schedules and timelines are adhered to.
    • Ensure that all content published in the Guidance Documents is consistent and in keeping with ISPE’s position on such topics.
    • Evaluate and implement tools for improving efficiency in Guidance Document development.
    • Provide oversight to the technical content, and the structure of that content, on the Society’s web-based publication platform.
    • Evaluate new strategies for delivery of content on the online publications platform.
    • Serve as primary Staff Project Manager to ISPE’s Knowledge Network Council as well as to Steering Committees for individual technical communities as needed, to ensure business objectives are achieved and key relationships are leveraged.
    • Train, supervise, and support Knowledge Network staff members to ensure they have the knowledge and resources required to support technical communities for which they serve as Staff Project Managers.
    • Collaborate with relevant staff and volunteer teams to continuously increase the awareness of Communities of Practice among ISPE’s membership to encourage active involvement and participation
    • Collaborate with relevant staff and volunteer teams to maximize the strategic participation of volunteer subject matter experts.
    • Oversee the Society’s prestigious Facility of the Year Awards (FOYA) program, including increasing the number of applicants for the awards.
    • Collaborate with relevant staff and volunteer teams to maximize the strategic participation of volunteer subject matter experts.
    • Provide communication and updates on the status of Business Plan deliverables to executive management and Board of Directors as requested.
    • Identify strategic opportunities and, if requested by senior management, develop and execute detailed design and implementation plans for new initiatives.
    • Support regulatory affairs initiatives as requested, ensuring alignment between these initiatives and other projects within technical communities and guidance documents.
    • Make recommendations, with data analysis when relevant, regarding stop-start-continue decisions for projects and initiatives under the department’s purview.
    • Supervise two staff members, the Technical Writer/Editor and the Manager of Community and Industry Recognition, as well as other contractors.
    • Other projects and duties as assigned by the Vice President, Marketing, Membership, and communications.

    Job Requirements

    Education and work experience

    • Bachelor of Science Degree in Engineering, preferably Chemical or Pharmaceutical, or a similar field
    • Minimum of 10 years of pharmaceutical industry experience supporting Engineering, Manufacturing, Quality Assurance, Regulatory and/or Development
    • Minimum of 5 years of experience in leadership or management role.
    • Minimum of 5 years of practical experience and documented success implementing, managing, and completing complex projects and initiatives in a matrix-based organization. International work experience and experience managing publications are a plus.
    • Minimum of 3 years working with and managing technical professionals
    • Experience working in an association and/or managing volunteers is highly desirable.

    Skills and Knowledge

    • Strategic mindset and results orientation.
    • Strong project management skills.
    • Ability to lead, manage, teach, and work collaboratively with others.
    • Strong analytical and organizational skills, attention to detail and follow through.
    • Creativity, adaptability, and decisiveness.
    • Strong written and verbal communication skills in English; proficiency in other languages is a plus. Interpersonal skills and cultural sensitivity are critical.
    • Strong PC skills, including proficiency with the Microsoft Office Suite. Word. Database proficiency is a plus.
    • Demonstrates professional appearance, ethics, and demeanor at all times.

    Location

    Prefer that the position be located at the ISPE Headquarters in Bethesda, MD or ISPE Operations Center in Tampa, FL but open to a REMOTE location.

    The above declarations are not intended to be an “all inclusive” list of duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are intended only to describe the general nature of the job, and are a reasonable representation of its activities.

  • Senior Director of Health Authority Outreach

    This position will serve as an ISPE liaison to the major health agencies and is responsible for building and strengthening relationships in support of the Society’s strategic plan. Act as the main point of contact for ISPE’s regulatory arm through strong interactions with agencies such as the FDA, Health Canada, among others.

    Principal Duties and Responsibilities

    Essential Functions:

    • Develop and maintain global regulatory contacts and their respective expertise. With regulatory volunteers and ISPE Consultant/Advisors, build relationships with key decision-makers in ISPE strategic areas of focus.
    • With Senior Director of Regulatory Operations, ensure effective ISPE regulator outreach such as speaker invitations, document commenting, document review, etc. and align with authority requirements or industry best practices.
    • Update volunteers and staff and on the impact of new or developing regulations/guidance/practices on ISPE offerings, e.g., apprise the ISPE Guidance Document team of potential impact on in-progress or planned ISPE Guidance Documents.
    • Identify regulations or emerging industry concerns addressed by current ISPE programs and products. Act as a technical resource for ISPE promotional efforts.
    • Monitor key health authorities to identify drafts meeting criteria for ISPE comment. Review comments developed by ISPE Comment Lead Teams and advise relevant committees and staff on the position(s) taken.
    • Work with Senior Director of Regulatory Operations to produce learning opportunities for staff.
    • Work to disseminate regulatory membership in ISPE and gain their participation on ISPE working groups, initiatives an as speakers and ISPE document reviewers.
    • Write, source, and/or review regulatory-focused content for ISPE publications including but not limited to:
      • Reports of ISPE regulatory activity.
      • Summaries of regulatory issues and activity with the potential to impact ISPE members
      • Summaries of ISPE comments on regulatory documents. Once a final version of a document ISPE commented on is released, a summary of any changes that reflect ISPE comments.
    • In collaboration with Senior Director of Regulatory Operations, regularly discuss industry and organizational activities/initiatives for purpose of reporting to the relevant committees, Board and where appropriate, the wider membership.

    Job Requirements

    Education and Work Experience

    1. Bachelor’s degree in science, technology, engineering or a related field required. MS/PharmD or PhD is preferred.
    2. 12 or more years’ experience of the pharmaceutical industry, preferably in Regulatory, R&D, Manufacturing, Quality or related area with minimum of 5 years in GMP/CMC.
    3. Experience interfacing with government regulatory agencies.
    4. Key regulatory agency experience is desirable. Recent FDA experience preferred.
    5. Demonstrable contributions to a relevant industry or professional association a plus.
    6. Experience of both small molecule (chemical entities) and biotechnology preferred.
    7. Established network of relevant contacts.

    Skills and Knowledge

    1. Must be a motivated self-starter with demonstrable leadership skills.
    2. Ability to establish and maintain partnerships.
    3. Must have strong writing, project management and communication skills.
    4. Must possess and demonstrate an excellent understanding of FDA and other global regulatory agencies.
    5. A passion for impacting better healthcare outcomes.
    6. Ability to speak English fluently and write to high standards is required. Fluency in other languages is a plus.
    7. Ability to interact with staff and organization leadership/volunteers (at all levels) in a fast-paced environment is required.
    8. Must be able to work under pressure, remain flexible, positive, proactive, resourceful and efficient, with a high level of professionalism and confidentiality.
    9. Excellent analytical and negotiating skills.
    10. Must possess multi-cultural sensitivity.
    11. Travel required.

    The above declarations are not intended to be an "all-inclusive" list of the duties and responsibilities of the job described, nor are they intended to be such a listing of the skills and abilities required to do the job. Rather, they are intended only to describe the general nature of the job and are a reasonable representation of its activities.

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