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 highquality medications Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust latestage pipeline. The company’s patientcentric products span the cardiovascular neurology endocrinology gastrointestinal institutional and orphan markets and have benefited millions of patients. For more information visit
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 evidencebased 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 investigatorinitiated trials (IITs) and labeling
Serve as the Medical lead reviewer for daytoday 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 patientfocused materials training materials payer market materials dossier development HEOR speakers’ bureau Sales training programs Azurity policies/SOPs
Communicate and collaborate effectively with crossfunctional 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 710 CORE responsibilities. It should not be a list of every single task.
Qualifications And Education Requirements
Doctorallevel 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 preemployment screening
35 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 handheld devices
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