An oncology focused pharmaceutical company in the Greater Boston area is looking to hire for a Senior Manager of Regulatory Labeling & Ad/Promo. The company is considering relocation assistance and evaluating their ability to provide remote flex once the COVID-19 situation has improved.
This is a permanent role with a research and innovative driven company who utilizes their core technology and novel drug development to help improve the lives of those suffering from cancer and other serious diseases. Their lead compound received accelerated approval from the FDA in July 2019 as a treatment for patients with heavily pretreated multiple myeloma. They have also begun to place a heavy investment in helping with COVID-19 relief effort. They recently announced the dosing of the first patient in their randomized Phase 2 clinical study, evaluating the effectiveness of one of their products in hospitalized patients with severe COVID-19.
Qualifications:
* 6+ years of experience in pharmaceutical industry.
* 2-4 years of ad promo experience.
* Previous experience in regulatory review of promotional materials.
* Background in prescription drugs and/or biologics.
* Background in oncology considered a plus.
Responsibilities:
* Providing regulatory guidance in the development and approval of compliant advertising and promotional materials.
* Act as Regulatory Reviewer on the Commercial and Medical Review Boards for assigned products.
* Utilize prior labeling experience in global regulatory affairs to oversee development of CPI (Country Product Information) components.
