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

  • Generous 401K Match
  • 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.

Back to Top


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.

  • Member Services Manager

    IMMEDIATE SUPERVISOR: Sr. Director, Membership & Chapter Relations
    DEPARTMENT: Member Services

    General Summary

    You are a change agent and can motivate and grow teams to be a highly functioning member centric team. You are someone that has demonstrated passion for excellent customer experience and has an innate sense of urgency. You love technology and you are comfortable with working with CRM systems to improve processes and the user experience. You also have no problem rolling up your sleeves and diving right in to help your team during high volume times.

    You will be responsible for leading the member services team and building a culture of accountability and excellent timely service. This role will also work closely with the sr. director of membership and chapters to launch membership engagement and retention efforts. You will also be the key business owner of the AMS solution iMIS and work closely with internal cross functional team to ensure the overall membership experience is of the highest quality and value.

    Principal Duties and Responsibilities

    Member Services

    • Manages the day-to-day operations of the Member Services team ensuring that resources and workflow are adjusted to meet organizational priorities, including cross-training so that excellent service can be maintained during periods of staff absences.
    • Meets all financial, operational and performance benchmarks as established in the annual Business Plan, Budget and individual performance plan
    • Supervises and trains staff to ensure efficient, accurate and exceptional service
    • Is proficient using the association's database, correcting errors, as well as generating lists and operations and benchmarking reports.
    • Establish team KPIs and metrics
    • Create scripts and talking points to increase member value
    • Provides backup to member services team during high-traffic times that may include answering member questions and requests, processing dues, publications, conference, training and other payments, data entry and maintaining up-to-date membership information
    • Maintain and develop processes and procedures
    • Other duties as assigned

    Membership Engagement/Retention

    • Track and report on membership numbers and trends, both current and historical; make recommendations for outreach and other activities based on trends
    • Evaluate recruitment and retention efforts for effectiveness
    • Conduct appropriate surveys to determine satisfaction with conferences, membership, products, and services
    • Oversees the execution of projects to support recruitment, retention and product sales initiatives
    • With collaboration of marketing and sr. director of membership & chapters, develop and implement campaigns and initiatives to increase and retain membership
    • Identify “at risk” members and determine appropriate initiatives to retain members

    iMIS Product Owner

    • Key champion and manages the association’s management system (AMS) iMIS
    • Owns all iMIS member processes working with IT and third-party vendors to enhance processes
    • Work closely with the IT department to manage the technical aspects of the AMS software for UAT, maintenance, upgrades, problem-solving, etc. and ensure security and back-up are functional
    • Suggests and implements initiatives to improve operations of the database to ensure faster and more efficient processing by the Member Services team
    • Assumes primary responsibility for collaboration and preparation of processes prior to events. Ensures that registration staff is properly trained to serve Members and attendees during the events
    • Online event and training registration setup and support

    Education and work experience:

    • Bachelor's degree or 2 years of college and 4 years of customer service experience
    • Three years supervisory experience required; 5 years preferred
    • Three years’ experience in CRM or AMS database management required; 5 years preferred
    • Experience with iMIS AMS preferred
    • Association experience preferred

    Skills and knowledge:

    • Strong written/oral communication and interpersonal skills
    • Astute problem-solving skills, and proven organizational and administrative skills
    • High degree of service excellence values and knowledge of how to create, measure, and deliver exceptional customer service
    • Positive supervisory demeanor that balances team orientation and mentorship with a commitment to a high degree of accuracy and excellence. Ability to lead and motivate customer service reps.
    • Ability to work independently with a high level of poise, diplomacy and confidentiality in all circumstances.
    • 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.

  • Managing Editor, Digital Properties

    IMMEDIATE SUPERVISOR: Director, Digital Experience
    FLSA: Exempt
    DEPARTMENT: Marketing Communications

    General Summary

    The Managing Editor, Digital Properties is charged primarily with establishing and managing editorial structures and processes driving the continuous flow of content to ISPE’s current website – ISPE.org – and its sister ISPE Foundation website, currently under development. This new position is critical to ISPE’s digital transformation focused on improving the value of digital touchpoints with members and stakeholders and will be a driving force in further expanding the Association’s thought leadership role in the pharmaceutical engineering space. The successful candidate will have demonstrated experience in building narratives on digital platforms, managing publishing workflows, working with content management systems, working with high-level industry professionals, and a passion for organizing information and digital publishing. This position provides the opportunity to combine strong writing, analytical, and organizational skills with creativity and innovation.

    This is a full-time salaried position with benefits that may be based either in ISPE’s North Bethesda, MD. or Tampa, FL. offices.

    Principal Duties and Responsibilities:

    • Oversee and manage content publishing operations for ISPE.org and ISPEFoundation.org (currently under development), as well as additional digital properties as the Society grows.
    • Establish and manage member editorial groups, comprised of high-level industry professionals, as well as freelance writers in the development of various types of web content.
    • Initiate new content and coordinate ongoing content management of the website with relevant staff and members, serving as a strategic partner.
    • Establish and maintain schedules for all editorial activities, including web publication schedules, publishing workflows, and content updates/archiving.
    • Edit technical content such as association news, blog posts, and technical articles as needed to include proofreading and line edits.
    • Provide expertise to guide improved digital content presentation, optimizing user experience, and use of graphics and multimedia content alongside traditional text-based content.
    • Use analytics to ensure that the website is user-friendly for both association members and outside audiences.
    • Support strategies to expand member engagement through continued growth and improvement of content and interactive features.
    • Implement and maintain a taxonomy system to support topic-specific content aggregation, as well as support advanced search/browsing of content across the association.
    • Maintain editorial integrity for content being posted across the organization to ensure consistency in voice, style, and brand representation.

    Requirements & Qualifications:

    • Bachelor’s degree in marketing, communications, library sciences, or related field.
    • Minimum 2 years’ experience in content development for websites and newsletters, preferably for a membership or nonprofit organization.
    • Experience with and proven capability in overseeing development of content in a technical discipline.
    • Excellent oral and written communication skills.
    • Demonstrated ability to manage complex projects requiring interdepartmental coordination and implementation.
    • Basic understanding and preferably experience with principles of information architecture.
    • Strong organizational skills, including the capacity to organize and synthesize complex information and multitask while maintaining attention to detail.
    • CMS experience (Drupal a plus); understanding of and ability to learn new digital technologies.
    • Familiarity with web metrics and web analytics.

    Additional responsibilities as assigned by the Director of Digital Experience

    • Additional Skills for Success:
    • Excellent communication skills to inform team members on process and procedures, and to problem-solve in a team environment
    • Strong collaborator with ability to work across various departments and teams to create results
    • A positive attitude – maintaining poise and professionalism in stressful situations
    • Strong attention to detail
    • Enthusiastic and willing to learn
    • A people person who is excellent at working with other people, teams, and building relationships
    • A problem solver – keen to understand customer needs and offer solutions
  • Managing Editor, Pharmaceutical Engineering magazine

    IMMEDIATE SUPERVISOR: Senior Director, Editorial
    DEPARTMENT:  Pharmaceutical Engineering Magazine

    General Summary

    The International Society for Pharmaceutical Engineering (ISPE) is seeking a Managing Editor to manage editorial and production operations for Pharmaceutical Engineering, its bimonthly print and digital magazine. The magazine highlights and supports the work of ISPE members, who manufacture pharmaceuticals around the world.

    Reporting to the Senior Director, Editorial, the Managing Editor works regularly with vendors and interacts with members of the society as well as internal departments including sales, marketing/web, conferences, and membership.

    Responsibilities:

    • Manage editorial and production from manuscript submission through publication in both print and digital formats, including:
    • Editing (substantive, copyedits, proofreading) of feature and technical articles; manuscript/page proof processing/tracking;
    • Peer review process management;
    • Prepare and post web site content;
    • Create print/mail orders;
    • Coordinate/supervise activities of external vendors, including freelance copy editors, design, print, reprint, and postage/shipping vendors, to ensure projects are on scope, within budget, and delivered on time;
    • Interact with the Pharmaceutical Engineering Committee and authors for follow up on pending content;
    • Occasional travel to conferences to cover sessions (including drafting articles for the magazine) and to meet with potential authors;
    • Periodic writing responsibilities to include conference coverage and other assignments as appropriate;
    • Update style guide.

    Qualifications, Knowledge, and Skills:

    • Bachelor's degree in journalism, communications, or similar field.
    • 5 or more years of magazine or journal editorial and production experience; scholarly publishing experience is strongly preferred. Experience in both print and digital publishing is required.
    • Ability to write/edit STEM (experience obtained through publications work and/or education or training).
    • Experience with nonprofit associations.
    • Experience with ScholarOne or other journal production and peer review systems.
    • Website content management system skills (Drupal preferred).
    • Superior organizational and detail skills, including the ability to set and maintain schedules and deadlines and handle concurrent tasks.
    • Outstanding editing skills, including proofreading, copyediting, and substantive editing of technical/scientific content.
    • Demonstrated expertise in managing editorial and production operations, including managing freelance, design, print, and shipping vendors.
    • Fast learner who embraces opportunities to take the initiative and helps to build content and brand.
    • Ability to deal tactfully with volunteer authors, peer reviewers, and association members.
    • Ability to work in a fast-paced, team-oriented environment.
    • Expertise with Chicago and AMA Manuals of Style.
    • Moderate to advanced skills in the Microsoft Office suite, especially Word, Excel, PowerPoint, and SharePoint.
    • Ability to travel occasionally and attend the annual meeting and other conferences throughout the year.

    Location:

    This position is based in Rockville, MD or Tampa, FL

    NOTE: Telecommuting is allowed.

  • Marketing Campaign Manager

    IMMEDIATE SUPERVISOR: VP, Marketing Communications
    FLSA: Exempt
    DEPARTMENT: Marketing Communications

    General Summary

    The Marketing Campaign Manager is responsible for overseeing the development and implementation of marketing campaigns for the Society to promote conferences, training programs, membership, products and other services. Working closely with colleagues in the Marketing Communications Department and business line leads across ISPE, the Marketing Campaign Manager will be responsible for the Society’s omnichannel promotional campaigns, to include all aspects of marketing project planning and execution, budget development and management, and campaign performance monitoring/reporting. He/she will manage and coordinate implementation of all marketing efforts, to include but not limited to digital advertising, SEM and SEO, email marketing, social media activity and print promotions.

    This is a full-time salaried position with benefits that may be based either in ISPE’s North Bethesda, MD. or Tampa, FL. offices.

    Principal Duties and Responsibilities:

    • Develop and ensure full execution of strategic marketing plans and tactics for key ISPE products and services. These plans encompass marketing of conferences, trainings, meetings, exhibits, advertising, publications, electronic products, membership, etc.
    • Manage Marketing/Communications projects to meet timelines and budgets; review and advise internal stakeholders on marketing campaign projects; and manage cross-functional relationships
    • Coordinate database queries for direct mail market list segmentation
    • Maintain and present to internal staff plans and progress reports on marketing campaigns for select projects.
    • Help create an organizational marketing strategy and plan to promote and support ISPE, its products and services, and enhance ISPE’s international reputation.
    • Develop, coordinate, and analyze marketing campaigns to achieve participation, engagement and revenue goals for events, membership, and other products and services.
    • Support marketing campaigns and strategy by gathering demographic and market research
    • Develop and manage marketing-related budgets.
    • Use marketing analytics to understand campaign results and refine efforts.
    • Provide quality assurance support (review, proofreading, etc.) in the creation of marketing materials such as promotional emails, advertising copy, exhibits and displays, marketing text and handout materials to better market products and services.
    • Develop and maintain a schedule of all communications outreach and marketing efforts to include project, due dates, audience, delivery method and actual date disseminated or launched. Coordinate the scheduling of marketing email, digital and print campaigns to optimize customer experience and marketing impact.
    • Develop reports following the delivery of programs (conferences, training programs) and launches of products detailing marketing effectiveness and impact, as well as lessons learned.

    Requirements & Qualifications:

    • Bachelor’s degree in marketing, communications, public relations or related field.
    • Minimum 3 years’ experience managing and conducting omni-channel marketing campaigns.
    • Strong understanding of customer and market dynamic and requirements
    • Demonstrated experience using marketing analytics to inform and improve campaign strategy
    • Knowledge of digital marketing tactics -- including social media, websites, blogs, paid advertising, paid search, etc. -- to market programs and services
    • Experience managing lists for marketing campaigns
    • Experience managing marketing campaign budgets in excess of $100K per year
    • Experience with nonprofits or member associations preferred
    • Superior written, proof-reading, and oral communications skills.
    • Experience writing marketing copy for a scientific/technical target audience.
    • Fluency with common office applications, including MS Office (Excel, Word, Outlook), Adobe software products, and related technologies.
    • Exceptional organizational skills and attention to detail and quality.
    • Proven ability to successfully manage multiple marketing/promotional campaigns in parallel.
    • Experience creating and testing new approaches for promoting products and services.
    • Excellent interpersonal skills, inspire trust, motivation, and confidence with internal and external stakeholders.

    Additional Skills for Success:

    • Excellent communication skills to inform team members on process and procedures, and to problem-solve in a team environment
    • Strong collaborator with ability to work across various departments and teams to create results
    • A positive attitude – maintaining poise and professionalism in stressful situations
    • Strong attention to detail
    • Enthusiastic and willing to learn
    • A people person who is excellent at working with other people, teams, and building relationships
    • A problem solver – keen to understand customer needs and offer solutions
  • 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.

  • Web Designer/Developer

    IMMEDIATE SUPERVISOR: IT Director
    FLSA: Exempt
    DEPARTMENT: Information Technology

    General Summary

    The Web Designer/Developer designs, develops, deploys, and maintains the organizations website with the goal of creating an amazingly interactive user experience for our target audience. This position manages the day-to-day activities related to the website and is involved with the short and long-term content goals of the organization. The ideal candidate will have a strong understanding of industry trends, open-source CMS knowledge, effective communication skills with both internal and external stakeholders, be confident and self-motivated, be able to provide solutions to assist in advancing the organizations web and online goals, willing to learn and stay abreast of technology and best practices, and be adaptable to changing priorities and initiatives. The Web Designer/Developer will with work closely with Marketing, Communications, Membership and Product Development teams on the user experience and the Information Technology team on technical backend functionality.

    Principal Duties and Responsibilities:

    • Act as key point of contact for day-to-day operations of the company’s websites.
    • Maintain the company’s Drupal CMS infrastructure by keeping it current with security patches.
    • Maintain the company’s e-commerce presence using proprietary, line of business CMS.
    • Understand, develop, implement, and maintain Drupal core modules, content types, views modes, views, groups, books, panels, blocks, custom modules, etc. to customize site behavior to achieve desired results.
    • Improve and maintain PHP code within custom modules and custom themes
    • Use a feature branch based Git workflow for requesting merge/pull requests
    • Demonstrate changes and new features in a test environment to get buy-in before deploying to live
    • Use expertise to improve the interaction between Drupal, proprietary CMS and other systems.
    • Use developer skills to troubleshoot any issues that may arise and provide innovative solutions to problems that cannot be solved out of the box
    • Develop customized landing pages to be used in paid advertising efforts
    • Develop new pages and make ongoing recommendations to improve the site’s navigation, content, functionality so the site remains visually appealing, easy to read, and navigate
    • Prepare wireframes, storyboards, user flows, process flows and site maps as needed
    • Perform thorough manual and automatic testing and quality assurance of all work rendered including testing web pages for appearance, functionality, and responsiveness in multiple browsers
    • Test site for usability on an on-going basis (i.e. form submissions, broken URLs, etc.)
    • Work with third party vendors to troubleshoot functionality issues and discuss future web development projects.
    • Work with stakeholders and content owners to understand business requirements to keep content and imagery on the website fresh and relevant for the best user experience and to ensure brand standards and best practices are adhered to.
    • Assist in developing and documenting content management system standards, guidelines, and processes for online content which are consistent with our brand guidelines
    • Assist in developing content strategy aligned with short-term and long-term marketing goals
    • Advise content owners on appropriate content and the best format for user experience, findability, SEO, etc.
    • Maintain a consistent look and feel throughout website
    • Stay abreast of trends in web design, coding, functionality, etc. to ensure we are adhering to web best practices and implementing technology as needed

    Requirements & Qualifications:

    • 3+ years of core experience with configuration, administration, design, development, and management of a website, using Drupal, or similar open source CMS and LAMP (Linux, Apache, MySQL, PHP) stack
    • Expert knowledge of HTML5, CSS3, Drupal Behavior Based Javascript, jQuery, ANGULAR JS1.x, PHP, MySQL db integration, SQL database infrastructure, and Git
    • Advanced knowledge of zurb Foundation grid system and SASS stylesheets
    • Intermediate experience with Drupal best practices that handle complex permissions, private files access, and implementation of Drupal core modules, views, panels, blocks, etc. and developing custom Drupal modules
    • Strong understanding of Redis cache, nginx, LAMP stack for collaboration in maintaining server configurations
    • Strong understanding of SQL to analyze and improve site content and locate site workflow issues specific to Drupal storage
    • Knowledge of Google Analytics and search engine tracking to apply to user retention
    • Expert user interface design skills
    • Ability to think critically, create compelling and innovative web pages and landing pages while working within the constraints of a template system
    • Advanced knowledge of best practices for web design and web usability
    • Ability to work well independently and collaboratively in a team environment
    • Exceptional stakeholder management
    • Strong organizational and time management skills including the ability to plan, prioritize workloads, balance multiple concurrent projects and work well under the pressure of tight deadlines and changing demands
    • Must be extremely detail oriented with a high degree of accuracy
    • Familiarity with design tools such as Photoshop, Illustrator, etc.
    • Understanding of digital marketing including basic SEO and PPC
    • Ability to review headlines and overall content for style consistency
    • BA/BS with specialization in web design and development preferred or relevant work experience
    • Portfolio of verifiable work on website of similar scope and complexity
    • Experience with international sites, a plus
    • Familiarity with email marketing software, a plus

    Additional Skills for Success:

    • Strong communication skills to inform relevant team members on process and procedures
    • A positive attitude – open and mindful to peer review from coding, design, and content perspectives
    • Strong attention to detail and cause/effect of all updates
    • Enthusiastic and willing to learn
    • Ability to analyze, prioritize and manage multiple ongoing tasks, feature requests and bug reports
    • Confident and self-motivated with a strong work ethic
    • A people person who is excellent at working with other people, teams, and building relationships
    • A problem solver – keen to understand customer needs and offer solutions

Submit Your Resume


To apply for an open position, complete the form below and upload your resume.

Name
One file only.
100 MB limit.
Allowed types: txt rtf pdf doc docx odt ppt pptx odp xls xlsx ods.