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Job openings

Below you can find all our current job openings. If you find one that suits you, let us know by applying today!

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Location: Stockholm - Remote
Apply by: 2024-04-01

We have an Office downtown Stockholm where you are welcome to join us for work. However, we are flexible if you prefer to work from home anywhere in Europe or East Coast North America.

As the Regulatory Affairs Manager you will be a member of the regulatory team, as well as representing Regulatory Affairs in cross-functional teams. You will support and lead activities such as planning for health authority interactions and submissions. In addition, you will work closely with the VP regulatory affairs, and team, in overseeing external regulatory vendors. You will lead the regulatory operational aspects and be a part of regulatory compliance and submissions for all projects across the company.

  • Responsible for establishing regulatory planning and tracking tools to ensure regulatory submission strategies are delivered in alignment with business needs.
  • Responsible for planning and managing regulatory submissions and support interactions with Health Authorities including scientific advisory meetings.
  • Coordinate the preparation, submission, responses to requests from regulatory agencies and follow-up contact with regulatory agencies for all applications and submissions.
  • Supporting regulatory compliance to be aligned with regulatory requirements and regulations.
  • Responsible for providing regulatory support to business development, including management of due diligence activities.
  • Support the Regulatory team and cross-functional teams in the global Managed Access Program.
  • Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise the Reg Affairs organization and project team accordingly.
  • As an Egetis Therapeutics member of the Regulatory Team, contribute to the overall development of the company and value creation.

Your background

Education

  • A Bachelor of Science degree or Master of Science (Biology, Pharmacy, Chemistry)

Experience

  • Experience from Regulatory Affairs in biotech and pharmaceutical industry, Rare disease drug development program experience is a big plus.
  • Experience of HA submissions in early and late development, supporting successful Phase I-III clinical trials submissions including INDs, CTAs (CTIS).
  • Global Experience of coordinating marketing authorisation applications is a big plus
  • Experience of regulatory management of expanded access programs is a plus.
  • Experience of electronic submission requirements and publishing.

Your Skills and Abilities

Skills and Abilities

  • Balancing stakeholders; Anticipating and balancing the needs of multiple stakeholders.
  • Action oriented; Taking on new opportunities and tough challenges with a sense of urgency.
  • Plan and align: Planning and prioritizing work to meet commitments aligned with organizational goals.
  • Communicate effectively
  • Manage ambiguity; Operating effectively, even when things are not certain or the way forward is not clear.
  • Being resilient; Adapting approach and demeanor in real time to match the shifting demands of different situations.
  • Ability to foresee long-term consequences of decisions.

Values

Naturally you share our values:

  • Courage - We challenge the status quo for the benefit of the patient
  • Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results
  • Collaboration – Through trust, we work seamlessly across functions and with external partners

Location: US - Boston - (Remote)
Apply by: 2024-03-20

As Head of Market Access and Pricing North America, you are responsible for the payer strategy, distribution, pricing, contracting, and HEOR for Egetis North America. You will build key alliances to optimize Egetis Therapeutics’ products access and reimbursement and contribute to maximize value generation throughout products lifecycle. Specifically, you will design and support the development and implementation of key strategic initiatives for an evolving health care environment for the upcoming launch and across the pipeline therapies including design and implementation of patient assistance programs for Egetis products. This position requires proven strategic commercial and scientific skills, and an understanding of the development, regulatory and commercial aspects of the pharmaceutical/biotech industry. As the person leading the Market Access effort in North America, you will work in close collaboration with other functions and the Global teams.  The role reports to the President North America and will also have a dotted line to the Global Head Market Access and Pricing. 

 Duties and responsibilities 

Market Access: 

  • Lead the development and execution of market access strategies in the US and Canada for new products 
  • Identify strategic imperatives, payers’ tactics and develop market access launch plan to optimize formulary coverage 
  • Identify gaps in current understanding of country specific payer needs, decision-making approaches 
  • Develop payer channels for insights, adapt Global value proposition, and develop payer communication materials 
  • Develop comprehensive payer segmentation and customer engagement plan,  
  • Develop strategies to bridge potential funding gaps to secure patients’ access to treatment 
  • Maintain relationships with key payers, serve as market expert, and manage specialty pharmacy programs and patient assistance initiatives 

 Health economics and outcomes research:  

  • Support the Global evidence generation plan development to address country specific payers’ needs in the US and Canada   
  • Identify specific gaps to meet market access needs and supplement existing Global evidence generation strategy   
  • Adapt/lead outcome research projects such as burden of illness and retrospective database studies  
  • Support the development of tools to raise payers’ awareness on the disease (burden of disease, spectrum of disease, patient journey) and to drive product awareness   
  • Lead the development / adapt health economic models to the countries setting    

 Pricing strategy and operations:   

  • Key contributor to the Global pricing strategy development  
  • Lead the pricing and contracting strategy for US and Canada, fully integrated within the Global pricing strategy, in collaboration with the General Manager and President North America and Global Market Access team 
  • Monitor innovative value-based pricing approaches and pricing analytics in the North America Region  
  • Support development of innovative pricing and reimbursement approaches, based on product value 
  • Develop payers’ negotiation strategies and contribute to a Global coordinated negotiation approach 
  • Establish and continuously update US and Canada pricing landscape, perform competitive intelligence pricing analysis, and efficiently produces decision-support analyses (business cases, trade-off analyses)  

 Overall 

  • Communicate and partner directly with cross-functional colleagues.   
  • Coordinate and oversee projects with external consultants as needed.  
  • Contribute to a culture that encourages others to be their best and speak up 
  • Produce well-written Word documents, PowerPoint presentations, and Excel spreadsheets that communicate key points in a crisp and concise format.  

 Experience and Education 

  • Bachelor's degree in health care, business administration, health economics, marketing or related; MSc, MBA or PhD in science and/or economics is strongly preferred 
  • 7+ years of progressively responsible experience within US managed markets, access functions in pharma industry or healthcare consulting, whereof at least 3 years in rare disease; market access experience in Canada is a strong advantage 
  • Experience supporting launch of new products in the US market and especially in rare diseases 
  • Previous experience from endocrinology or neurology therapeutic areas is a plus 

 Competencies and skills  

  • Full functional knowledge of the US reimbursement landscape for pharmaceutical products, including private and state payer programs 
  • Knowledge of the reimbursement landscape and process in Canada is a strong advantage 
  • Ability to build relationships with Managed Care, Trade, Government executives 
  • Good understanding of regulatory, legal, and compliance requirements  
  • Excellent communication skills and the ability to build relationships quickly and credibly to work effectively with cross-functional teams 
  • Strong analytical, creative problem solving and strategic thinking skills 
  • Strategically agile with interpersonal savvy 
  • Demonstrated success in small, entrepreneurial environment through a hands-on, solution-oriented approach 

Values 

Naturally, you share our values: 

Courage - We challenge the status quo for the benefit of the patient. 

Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results.  

Collaboration – Through trust, we work seamlessly across functions and with external partners. 

Egetis values diversity and is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, marital or veteran status, genetic information, sexual orientation, or any other legally protected status. Egetis will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law. 

 Note to Third Party Staffing Agencies: Please do not forward any agency resumes. Egetis is not responsible for any fees related to resumes that are unsolicited. 

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