Alexion Pharmaceuticals Sr Manager, Alliance & Vendor Management in Boston, Massachusetts
The Senior Manager, Global Drug Safety Vendor and Alliance Management is responsible for the preparation of vendor/alliance exchange agreements and support processes, and will provide vendor relationship management. Position ensures compliance to Alexion’s Standard Operating Procedures (SOPs) and guidance documents for vendor/alliance exchange agreements and vendor management. The position will liaise with groups both internal and external to Global Drug Safety (GDS) regarding these activities. The Sr. Manager, Global Drug Safety Vendor/Alliance Management reports to the Director, Global Drug Safety Intake, Policy & Vendor/Alliance Management.
Job Duties & Responsibilities
Develop Pharmacovigiance Agreements (PVAs)/Safety Data Exchange Agreements (SDEAs) and support processes in accordance with SOPs
Own end-to-end process of development, execution, maintenance,and termination (when applicable) of PVAs and associated deliverables
Supports affiliates with pharmacovigilance language in all local agreements including, but not limited to, licensing, pharmacovigilance and distribution agreements
Ensures all agreements (e.g., marketing, co-marketing, co-development, acquisition, clinical study, distributor, manufacturing and supply) contain pharmacovigilance and product complaint language that complies with worldwide regulations as well as corporate and departmental SOPs
Responsible for tracking status of PVAs/SDEAs and maintaining GDS’ database of associated contracts
Supports internal and external audits and inspections impact on vendors and business partners
Supports and contributes to continuous improvement to the business partner alliance and vendor selection and management processes and templates
In collaboration with GDS colleagues, ensures vendor delivers high quality services and products in a timely manner to meet all worldwide regulatory authority requirements
In collaboration with GDS colleagues, monitors key performance and compliance indicators and works with vendors and business partners to ensure metrics meet Alexion quality standards
Bachelor’s degree required, advanced degree in scientific or technical area preferred
Minimum of 5 years' pharmaceutical experience, with at least 2 years in drug safety
Advanced understanding of medical concepts and terminology
Demonstrated knowledge of global aspects of pharmacovigilance
Experience in drafting agreements
Experience in managing business partner agreements and vendor relations
Excellent attention to detail
Excellent oral and written communication skills
Analytic and strategic thinking in complex multi-cultural situations
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.