Careers

Job Postings 2018-01-24T00:49:45+00:00

Join Our Team.

We seek highly motivated professionals to join our team. We invite you to schedule a visit through Human Resources to learn more about our company and see our current open job postings below.

We participate in E-Verify, the US Government sponsored right-to-work verification process.

Administrative

Responsibilities and Job Duties

  • Travel arrangement (flight, hotel, car, conference registration)
  • Obtain scientific journal articles (purchase electronically, print and distribute)
  • Reconcile AmEx bill each month
  • Prepare expense reports
  • Schedule and set up teleconferences
  • Arrange lunch for meetings
  • Assist with Power Point slides, articles and poster presentation
  • Manage ReqLogic purchasing requisitions and signature folder
  • Manage and update the company calendar on a monthly basis in the copy room
  • Track all employee vacation and sick time
  • Prepare Time Off Report for each pay period.
  • Schedule candidate interviews (work with recruiters, finalize schedules, coordinate flights and accommodations for out-of-state candidates)
  • Maintain an organized Supply Room (unpack any incoming supplies, refill paper in all printers and faxes, manage toner and shipping supply inventory
  • Generate PO requests
  • Stock break rooms, Boardroom and conference rooms with various supplies
  • Collect, sort and distribute daily incoming mail
  • Be on call for all Board of Director meetings to assist with all necessary logistics including preparing Board books for distribution
  • Order lunches for internal committee meetings
  • Other projects as assigned
  • Assist other admins
  • Answer the main phone line
  • Maintain corporate files, both electronic and physical
  • Order weekly catered lunch, set up and clean up, and store remaining lunches
  • Assist with other annual corporate events
  • Assist Patent Agent with NDA and coordination to obtain signatures
  • Coordinate Lab Notebooks collection, scanning, and archiving

Desired Skills and Experience

3-5 years’ experience in administrative roles or equivalent. Associates Degree or BA/BS preferred

Submit Resume

Clinical

We seek someone with demonstrated strength and success in project and program management to plan and execute on clinical stage therapeutic candidates. The candidate will plan and direct critical schedules and budgets and will ensure effective outcomes throughout all phases of a project. The Manager will drive the development of high-quality and integrated cross-functional plans in support of our projects. This person will be responsible for project performance, risk management, administration, financial management and issue resolution for the functioning group. The successful candidate applies best practices in the development, initiation, planning, execution, control and closing of projects.

  • Oversees program plan development, tracks and updates milestones and key activities
  • Establishes and maintains integrated project schedules to ensure accurate project, financial and portfolio analyses; aligns with functional partners and project sub-teams
  • Collaborates with Clinical, Finance and Research and Development in the preparation of budgets, other resources and costs.
  • Develops detailed project plans, milestones, timelines and corrective action.
  • This person must build strong working relationships across departments, with key stakeholders and senior management.
  • Effectively communicates with all levels within the organization, documents and maintains project team outcomes, activities and decisions.
  • Facilitates project team meetings, cross-functional information sharing and ensures alignment.
  • Balances conflicting priorities across multiple objectives or programs and has the ability to articulate risks and trade-offs.
  • Manages and can operationalize a set of alliance partnerships to drive their success and growth.
  • Builds and maintains strong relationships with a diverse set of internal and partner contacts, including senior level executives.
  • Facilitates ongoing communication to understand key interdependencies, drive decision-making, issue resolution and execution across collaborations, as well as keeping all stakeholders informed and up to date on collaboration details.
  • Performs other duties as required.

Title and reporting structure is commensurate with experience.

Who We Seek

  • BS or BA in Life Sciences. An advanced degree, MS,MBA or Ph.D.is preferred; however experience and accomplishment will be considered in lieu of advanced degree.
  • The preferred candidate would have a PhD in chemistry, biology or biomedical engineering with excellent working scientific knowledge of all areas. He/she would have several years’ experience in biotech industry project management, particularly at the early and Phase 3 development stage and would have worked within the context of an active industry alliance
  • Multidisciplinary knowledge of biotechnology/pharmaceuticals
  • 5 years-experience in project management in support of drug development
  • PMP and other certifications preferred
  • Ability to establish and maintain positive relationships with partners at all levels and across various disciplines.
  • Expertise and accomplishment in drug development methodology, to include project management practices, methodology and tools
  • Proven results in managing strategic alliance partnerships that have generated significant revenue through sell-with and sell-through models.
  • Has financial acumen; can plan and manage budgets; metrics
  • Excellent management, leadership and interpersonal skills
  • Attention to detail, action oriented and outcome focused
  • Strong written, verbal and platform skills
  • Experience in using project management software to manage budgets, timelines and outcomes

We participate in E-Verify, the US Government sponsored right-to-work verification process.

Submit Resume

Regulatory

Summary

Contractor Regulatory Affairs Associate, with a focus on clinical and nonclinical aspects, will participate as a member of the regulatory team in the development and implementation of global regulatory strategy worldwide for products serving patients with rare diseases and unmet medical needs. This individual will be responsible for assisting with the development and coordination of regulatory submissions, with input from cross-functional team members, to support regulatory filings, agency meetings, and overall program priorities.

Responsibilities

Responsible for organization of cross-functional activities pertaining to regulatory function, including the development of meeting requests, timelines, and compilation of briefing documents intended for submission to regulatory authorities.

  • Actively participate in regulatory meetings on defined topics with a clear objective. Author and archive meeting minutes.
  • Maintain regulatory dossiers in compliance with global health authority requirements.
  • Participate in the development of regulatory submissions for assigned products and regions.
  • Interact with other global project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
  • Interact with internal and external partners as necessary to support product development.
  • Conduct and analyze regulatory research to understand past precedence and the current competitive landscape.
  • Educate internal stakeholders on implications of regulations.
  • Provide logistical support for meetings with US and ex-US regulatory agencies.
  • Support the preparation of responses to questions and comments from regulatory agencies.
  • Support the filing and archival of regulatory documents, study reports, etc.

Experience

Required Skills:

  • Minimum 4 years of regulatory affairs experience or equivalent combination with advanced degree.
  • Understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories. Experience with global regulatory dossiers desirable.
  • Excellent written, verbal, and organization skills, with strong attention to detail.
  • Strong communication (verbal, written, listening) and interpersonal skills with the ability to communicate cross-functionally in a collaborative manner.
  • Preferred experience with eCTD document formatting and publishing, and the use of regulatory authoring templates.

Education

Bachelor’s degree required. Prefer life sciences or related major.

Contract for 1-6 months.

Submit Resume