Medical Affairs Manager

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity’s success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief Team/department Description

We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Working at Azurity offers a unique opportunity that combines the fast pace and growth opportunities of a startup with intellectual rigor and creativity.

As part of the Medical Affairs team, the Medical Affairs Manager will be responsible for supporting the execution of the Medical Affairs Strategy and managing the timely, compliant, and evidence-based medical review for PMRC and SRC. This position reports to the Associate Director of Medical Affairs.

Principle Responsibilities

This should specifically outline, in bullet form, the responsibilities of the job:

• Conduct ongoing Medical reviews of scientific, advertising/promotion materials, grant requests, investigator-initiated trials (IITs), and labeling
• Serve as the Medical lead reviewer for day-to-day promotional and scientific review committees, while using good judgment to know when to escalate issues/concerns to the Associate Director of Medical Affairs
• Utilize professional and clinical judgement to critically evaluate the scientific accuracy of manuscripts/publications, clinical studies, and outcomes research on Azurity’s and competitor’s medications
• Support content development in concept and/or draft phases within the Medical Affairs and Commercial teams, including MSL training, MSL content, Scientific Communications, Medical Information, and training; including Medical Affairs project submission in Veeva Vault as needed
• Develop, manage and provide input on several key programs/new initiatives within Azurity Medical Affairs, including manuscripts/publications, Scientific Communications vendors, patient-focused materials, training materials, payer market materials, dossier development, HEOR, speakers’ bureau, Sales training programs, Azurity policies/SOPs
• Communicate and collaborate effectively with cross-functional teams to cultivate a strong relationships to drive results
• Maintain scientific knowledge, including: labeling, associated therapeutic areas, relevant literature, treatment guidelines and competitor information, through ongoing internal and external data sources (e.g., training, conferences)
• Participate in internal meetings to remain current on relevant brand and overall company strategy

This should have 7-10 CORE responsibilities. It should not be a list of every single task.

Qualifications And Education Requirements

• Doctoral-level qualification (PharmD, PhD, MD) preferred. Master’s in a related field and 3+ years relevant experience may substitute.
• A thorough understanding of the science and medical standards of care are essential
• Direct promotional/medical review experience in pharmaceutical and/or biotech company
• Strong scientific/medical written and verbal communication skills required
• Successful completion of pre-employment screening
• 3-5 years pharmaceutical or biotech industry experience
• Ability to communicate highly scientific and technical medical information
• Demonstrated leadership ability
• Effective administrative / organizational skills

Physical & Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be able to sit for long periods of time
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
• May occasionally climb stairs and/or ride elevators
• The employee must occasionally lift and/or move up to 25 pounds
• Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
• Other miscellaneous job duties as required