Why CorMedix?
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The company is focused on developing its lead product candidate DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. At CorMedix we are passionate about what we do each and every day! We provide comprehensive benefits and competitive compensation. If you are looking to join a team that puts the patient first and is changing the way that healthcare is delivered – let’s talk!
Company Description:
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. Our Company is focused on developing its lead investigational drug product, Defencath™, a novel, antimicrobial and antifungal solution designed to prevent catheter-related bloodstream infections (“CRBSIs) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter. Recently, the Company submitted the New Drug Application (NDA) for Defencath™ to the Food and Drug Administration (FDA). Future research and NDA’s submissions may include indications for similar infectious outcomes in oncology, ICU, and patients receiving total parenteral nutrition (TPN).
Position:
As the Associate Director / Director, Medical Affairs, you will be responsible for implementing the day-to-day operations of medical affairs strategic initiatives. This role will report to the EVP, Head of Clinical and Med Affairs and requires a strong skillset in coordinating with internal and external stakeholders and managing logistics and vendors. An important aspect of the role is to ensure following our compliance policy including reporting standards on grants, research, education and engaging health care professionals at Congresses and meetings.
You will be expected to travel to HQ in Berkeley Heights, NJ on an as needed basis.
PRIMARY RESPONSIBILITIES:
- Support the Executive Director (ED) in development of the Medical Affairs strategy and execution of the Medical Affairs plan related to evidence generation, medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing budgets and resources in collaboration with ED.
- Build slide decks, dashboards, and Medical Affairs project communications.
- Support medical readiness activities for market launches and life cycle management.
- Support ED in developing, executing, and managing company-sponsored evidence generating studies/projects in collaboration with Clin Ops and other cross-functional stakeholders.
- Collaborate with publication steering committee. Support the ED in publication strategy and plan and corresponding scientific platform. Track deliverables needed, writing process, and timelines w/team members, ensuring a high quality and timely work product, and adherence to Publication Policy and associated Procedures.
- Participates in scientific exchange w/the external HCP and advocacy communities; works with field medical and ED to collate and analyze insights to e.g., inform strategy, identify data gaps.
- Co-leads selecting medical education and other scientific exchange activities in alignment with the ED, such as scientific symposium and medical congresses. Work cross functionally (Med Com/Pub, field medical, corporate, commercial, regulatory, and legal) to prepare for pre-Congress and on-site team training and Congress debriefs.
- Support and coordinate educational and research investigator-initiated research [IIR]) grant requests/review process. Assess for appropriateness and compliance with CorMedix criteria, policies and procedures. Participate in and track/record grant review meeting output. Route all end-to-end communications (Requests for Info, payments, documentation/reconciliation, etc.) through entire grant life, ensuring records are up to date.
- Ensure overall compliance and quality of medical education programs, working collaboratively and efficiently with all internal and external customers, partners, and other stakeholders.
- Provide operational expertise and support for a collaborative IIR program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements. Ensure all IIR program records are up-to-date and accessible for team use and audit-readiness.
- Work with Legal Department and Finance business partners to develop and negotiate contractual elements and payment schedules.
- Evaluate and confirm all invoices as per company policy and perform payment assessments required for budget reconciliation.
- Work with Medical Affairs stakeholders, internal partners, and external vendors to develop and monitor other Medical Affairs initiatives as needed.
- Collaborates across functions to support MA LMR activities in order to achieve approval of key scientific communications resources.
- Assist with other duties related to the Medical Affairs Operations function.
SKILLS & REQUIREMENTS:
- Prior experience with medical affairs operations is required (minimum 3 years)
- PharmD, MD (or equivalent), PhD, or advanced practitioner (PA-C, NP) preferred. Masters level in a relevant field with previous MA experience would be considered.
- A proven track-record in a relevant medical/scientific role, preferably in the pharmaceutical industry and with product launch experience, including working with the cross-functional brand, market access and launch team.
- Strong interpersonal, presentation and communication skills and demonstrated ability to work collaboratively in a dynamic, team-oriented environment
- Strong organizational skills and business planning, including development of a budget and adherence to targets and timelines
- Manage and adhere to CorMedix policies, ensuring compliance with industry rules and government regulations governing scientific interactions with HCPs, professional organizations, and the public
- Results oriented, with high standards for individual and team execution and achievement
- Entrepreneurial mindset, motivated by start-up environment with the ability to deal with ambiguity
- Meet challenges consistently and confidently with energy and drive
- Possesses high integrity and exceptional work ethic, effective stakeholder, and relationship management
- Proficiency in systems and tools (Outlook, Microsoft suite, etc.)
- Travel required to medical congresses, KOL, SAB and other meetings (approximately 30%)
- Develops and conducts medical education and communication activities, including digital, face-to-face, and print.
- Is involved in scientific publication activities. Supports the generation of scientific data through collaboration with the CorMedix personnel in R&D and Clinical Operations, site support in clinical trials, and by developing local clinical trials including study protocols, as needed.
- Is a company representative to groups of experts, medical professional groups, societies, patient representatives, regulatory groups, and represents the company at national and international scientific meetings.
- Establishes and maintains strong working relationships with external medical experts locally and internationally, including academic societies.
- Plans and conducts Advisory Boards as needed to obtain insights.
- Presents scientific and clinical data in a variety of different settings.
- Works collaboratively with CorMedix personnel in Medical Affairs, Clinical, Marketing, Market Access, Sales, Regulatory Affairs, Drug Safety.
- Only candidates with industry experience will be considered.