Associate Director, US Medical Review

This is what you will do:

The Associate Director of US Medical Review leads the Medical Review as part of the MLR team.  This person is accountable for medical review activities for assigned therapeutic area(s), as well as contributes and implements department strategic imperatives and objectives.  The Associate Director is accountable for aligning pre- and post-launch plans with internal constituents in Medical Affairs, Commercial, and Clinical Development Teams.  Success of this individual is highly dependent on the ability to collaborate cross-functionally and understand business strategy.

In addition, the Associate Director will provide essential medical and scientific expertise, review, advisement and oversight to support development of high quality promotional and medical materials, internal training materials, and communications as part of the Promotional Review Committee (PRC) and Medical Review Committee (MRC).

The employee carries out this role in accordance with departmental SOPs, corporate policy and other legal and regulatory requirements.

You will be responsible for:

• Representing medical function in the Medical & Promotional Review Committees and ensures scientific / medical / clinical accuracy, relevance and completeness of data and that promotional claims within materials are adequately supported by data.
• Leading planning, prioritization, and execution in alignment with internal stakeholders (US Medical Affairs, Commercial, Clinical Development) to ensure adequate resources for Medical Review for product launches.
• Developing / maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.
• Training and mentoring, Managers, and Fellows to ensure alignment with operational objectives, excellence in execution, and maintenance of quality performance. 
• Providing medical / scientific expertise to commercial teams for appropriate disease and product claims development.
• Providing mentorship on ethical, legal and regulatory standards for product promotion and scientific exchange.
• Developing / maintaining current, broad, and in-depth knowledge of US regulatory and advertising compliance requirements / limitations applicable to promotional and non-promotional materials; as well as responding to unsolicited requests for medical information.
• Assisting in the development / maintenance of departmental Policies, Standard Operating Procedures (SOPs), WPDs (Working Practice Documents), and Work Instructions (WIs).

You will need to have:

• Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) with 5 years of medical information or medical communications experience in the pharmaceutical / biotech industry
• 2 years of experience in reviewing US promotional materials
• Thorough knowledge of the regulatory and compliance requirements / limitations applicable to medical information, as well as advertising / promotional and non-promotional pharmaceutical materials
• Experience in developing work practice documents, SOPs and effective training materials
• Excellent written and verbal communication skills
• Demonstrated ability to achieve aligned objectives in a matrixed environment.
• Team player in a multidisciplinary, cross-cultural environment, high level of flexibility
• Strong skills in project planning, courageous/challenging decision-making, problem-solving, and negotiating towards mutually beneficial outcomes.
• Highly proficient with Microsoft Office Suite
• Ability to travel to meetings / conferences (including internationally) approximately 20% of the time.
• The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Experience providing medical information/medical communication support.
• 3 years of relevant experience in review/editing promotional or scientific materials
• Training or experience in assigned therapeutic area(s) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies.