Contract, US Medical Information Reviewer

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

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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