Sr. Dir/Dir, Medical Affairs - Azur Pharma, Inc

Position Description

Azur Pharma, Inc., a rapidly growing privately held specialty pharmaceutical company with commercial franchises in CNS and Women’s Health, and an emergent pipeline, is seeking candidates to fill the head of Medical Affairs role.

The purpose of this role is to oversee the operation of Azur’s medical affairs, medical safety and pharmacovigilance functions, providing for the support and fulfillment of compliance requirements related to the product portfolio, and the collection and control of necessary documentation. The successful candidate will manage the company’s medical safety staff, home office and field based medical affairs teams, which, amongst other activities, support Azur’s FDA mandated patient registry for FazaClo, an anti-psychotic drug.

In addition, this position is responsible for:
 Leading team to provide medical expert responses to requests for medical information;
 Developing and implementing medical education strategies and initiatives (publication plans, advocacy and KOL development and medical communication plans);
 Providing oversight of Investigator Initiated Studies (IIS) and chairing the grants committee;
 Leading the promotion materials review committee (PRC) process including managing the PRC meeting interfacing regulatory, legal, and clinical review;
 Continually reviewing developments relating to DDMAC guidance and regulations, and providing updates to leadership team as needed;
 Participating as a member of the Corporate Compliance Committee;
 Developing and managing commercial compliance issues with reference to SOPs and PhRMA/FDA guidelines;
 Overseeing Azur’s speaker programs including training and honoraria;
 Providing technical and clinical assessments with regard to corporate acquisitions and products in development.

To be considered for this role, the successful candidate will hold a Doctorate Degree in Medicine (MD) to include board certification; Seven or more years of work experience in the biotech and/or pharmaceutical industry, which will include 5 or more years of direct experience within a medical affairs managerial role with experience participating in or managing pharmacovigilance and product safety; experience managing outside/contract vendors; Strong communication skills; Experience in neurology, CNS or schizophrenia preferred.

This position offers a competitive compensation package, access to the Company benefit package and the opportunities that accompany working with an entrepreneurial Pharmaceutical company.

To be considered for this position, the well qualified candidate should send a resumes (referencing the job number) and salary requirements to:

Azur Pharma, Inc. / Human Resources
1818 Market Street, Suite 2350, Philadelphia, PA 19103
e-mail: jobs@azurpharma.com, Fax: 443 487-9252

Azur Pharma is an Equal Opportunity Employer.EOE M/F/D/V

How to Apply