Associate Director, Regulatory Affairs Strategy
Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The candidate will manage, and lead regulatory submission-related activities associated with the US and ex-US fillings for assigned products, ensure timelines are appropriately managed and met, and issues are appropriately raised and resolved in a timely manner. Represent regulatory affairs on assigned project teams and support R&D and clinical research activities.
Associate Director, HCP Marketing
Reporting to the Director of HCP Marketing, this hire will play a key role in HCP marketing activities in the US for our current and future ultra rare disease breakthrough therapies.
The Associate Director of HCP Marketing will be responsible for driving the implementation and execution of HCP marketing activities in support of NS Pharma’s objectives and growth plan. This person will be responsible for the implementation of disease state education and promotional materials for the sales force and non-personal channels. They will be responsible for ensuring strong cross-functional alignment in the seamless execution of strategy and promotional tactics working in close collaboration with internal and external stakeholders.
Associate Director, Caregiver/Patient Marketing
Reporting to the Director of Patient/Caregiver Marketing, the Associate Director of Caregiver/Patient Marketing will play a key role in NS Pharma’s patient-centric marketing activities in the US for our current and future ultra rare disease breakthrough therapies.
The Associate Director of Caregiver/Patient Marketing will assist in the creation of promotional materials that enhance disease understanding and treatment benefits using scientifically sound and market-based insights. The Associate Director will collaborate with internal and external stakeholders to ensure strong cross-functional alignment in the execution of strategic and tactical priorities.
Executive Senior Director, Regulatory Affairs
Reports to the Vice President of Research and Development with the primary responsibility to develop and implement comprehensive global regulatory strategies (except Japan) in all stages of clinical development (preclinical to commercial) to ensure timely and successful interactions with global health authorities.
Associate Director, Alliance Management
The Associate Director, Alliance Management will focus on developing and monitoring the progress of our program milestones and goals for NS Pharma’s various collaborations. This individual will be a self-driven individual with proven relationship management experience and will serve as a point of contact for alliance partners as well as headquarters in Japan This role will report to the Sr. Director, Alliance Management.
Director, Market Access Marketing-Communication
Responsible for market access insight gathering and building & implementing market access product reimbursement & coverage communication tools to be used by DPAs, NADs, appropriate NSP associates and select customers. Building of market access programs. Managing market access agency relationships and budgets. Work collaboratively with NSP cross-functional partners such as patient services, marketing, operations and medical.
Associate Director / Director, Drug Safety
This position oversees the outsourced Drug Safety and Medical Information Call Center activities for NS Pharma. This position is responsible for the review of all US spontaneous safety reports and global Clinical Trial safety reports, as well as the review of various regulatory documents such as the PADER, NDA Annual Report and the PBRER. In addition, a review of global regulatory submission documents is conducted as needed. This person will also have oversight of the Medical Information Call Center to respond to escalated questions and draft response letters as needed.
Associate Director, Clinical Research
Responsible for the management and execution of various aspects of clinical studies (implementation, site selection, patient recruitment, vendor oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements.
DMD Patient Engagement Lead (PEL)
Reporting to the Sr. Director, Patient Services, the PEL position is a key field-based member of the Patient Services team, who is a patient and community-facing colleague who serves as a patient educational resource for local advocacy groups, their patient members, and Duchenne Muscular Dystrophy (DMD) patients enrolling into NS Support® patient services. The PEL is responsible for educating patients/caregivers on understanding the steps required to gain access to therapy and serving as a primary liaison to patients. An additional function of the PEL is to liaise with community-based advocacy and patient groups and their constituents on approved programs, resources, support and services available from NS Pharma.
Director of Patient Access (DPA) supports all Market Access touchpoints to include Healthcare Processional (HCP) and Duchenne Muscular Dystrophy (DMD) Clinic processes dealing with Authorizations, Site-of-Care solutions, NS Support communication and collaboration with all NS Pharma support team members. Additionally, DPA will strategize for process solutions within compliance guidelines.
As part of the NS Pharma team, the Director, National Training will be responsible for developing and executing a comprehensive training plan will drive and imbed a continuous learning and development culture to meet the evolving needs of the US commercial organization.
National Account Director (NAD)
The National Account Director (NAD) is an NS Pharma employee who is primarily responsible for managing business transactions and/or relationships with national insurers, PBMs and multiple types of accounts across geographies versus being tied to one type of account that is in a set or more regional geography. The NAD represents NS Pharma no matter the location of the account within a national USA geography, but typically not internationally.
The National Account Director (NAD) will report to the Sr. Director, Market Access and will be responsible for managing all segments of the market access business within their assigned accounts. The person will work collaboratively with Sales Leadership, Directors of Patient Access (DPA), Market Access Marketing and Medical.
The NAD will be responsible for national insurers, key PBM/GPOs, FFS & Managed State Medicaid programs, regional managed care organizations, Medicare, and medical management firms. They will also interact within a broader Market Access team and ultimately be responsible for implementation of tactical plans developed by the market access team. In addition, the NAD will provide critical competitive intelligence within the market access marketplace to executive leadership. The individual will provide updates, direction, and input to the NS Pharma leadership team and assist in the development of the overall market access strategic plan. The ultimate goal of the position is to minimize NSP product access barriers and promote/implement various programs and services to supplement the DPA’s, field sales force and management efforts. Plan and develop strategies for long term access solutions for pipeline.