• Job Description

  Req#: R3587

  PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

  At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

  Visit our website to learn more about our company and culture!
  Site: www.ptcbio.com

  Job Description Summary:

  The US Medical Information Reviewer conducts the medical and scientific accuracy review of materials which have been submitted through PTC’s global medical, legal and regulatory (MLR) and medical quality check (MQC) processes for marketed products and investigational drugs; contributing to the production of high quality and impactful pharmaceutical promotion and scientific exchange.
  The incumbent works cross-functionally with internal departments and external resources for US MLR and MQC related matters and provides support for global MLR and MQC review as needed.
  The Medical Information Reviewer ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

  Job Description:

  ESSENTIAL FUNCTIONS

  Primary duties/responsibilities:

  • Reviews MLR and MQC materials and ensures all materials are accurate and aligned with scientific and medical data sources.
  • Builds positive relationships and works independently, proactively and collaboratively as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Anticipates environmental change and communicates across therapeutic areas globally.
  • Collaborates with commercial, regulatory, legal, and compliance counterparts to cultivate efficiencies that have company impact.
  • Serves as key resource to organizational counterparts.
  • Manages escalations in cooperation with the wider MLR and MQC teams
  • Collaborates with management to implement risk management strategies related to medical information review.
  • Provides assistance with other medical information review activities as required by manager.

  KNOWLEDGE/SKILLS/ABILITIES REQUIRED

  * Minimum level of education and years of relevant work experience.

  • A pharmacy or life science degree at bachelors’ level or above, and a minimum of 3 years of related professional experience OR equivalent combination of experience and/or education.
  • Experience of medical information review from a US perspective

  * Special knowledge or skills needed and/or licenses or certificates required.

  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Proficiency with Microsoft Office, Veeva Promomats and Veeva Medcomms
  • Excellent verbal and written communication and skills.
  • Excellent people skills, with the ability to work collaboratively as a team player

  *Special knowledge or skills and/or licenses or certificates preferred.

  • Knowledge of medical information enquiry handling and operational experience.
  • Project management experience.
  • Experience of medical information review of medical and marketing materials at a global level

  * Travel requirements 10%

  US Office or remote based position

  Expected Hourly Range:

  $59 – S74. The hourly salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

  In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

  EEO Statement:

  PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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• About the company

  PTC Therapeutics is a US pharmaceutical company focused on the development of orally administered small molecule drugs and gene therapy which regulate gene expression by targeting post-transcriptional control mechanisms in orphan diseases.

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