Medical Affairs Manager - Brighter AB
Talentor Sweden AB / Elektronikjobb / Stockholm
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hela Sverige Our client, Brighter AB, is a Swedish-based company that, from a unique IP portfolio, creates smart solutions for one of the most serious healthcare problems: changing patient behavior. Chronic diseases such as diabetes are rapidly increasing and account for an increasing share of healthcare costs globally. Blighter's Business Model and Multi-Sided Market Platform - The Benefit Loop® - is based on the fact that many special interests create value for each other. By increasing access to valid health data, Brighter creates value for all stakeholders in the care chain: patients and close associates, healthcare providers, research, pharmaceutical industry and society. For more information;
https://brighter.se/As Brighter is expanding we are looking for a dedicated individual to take the manager role of the newly established function of Medical Affairs.
Your future role:
In your role as Medical Affairs Manager you will be responsible to maximize the leverage of clinical data generated by Brighter AB and establish the clinical process that enables the generation of high-quality clinical data in the most efficient way.
The role includes, but is not limited to, the following tasks:
1) Generate real world data (RWD):
a. Drive collection of clinical data, GAP analysis comparing existing clinical data with Brighter's own clinical data evidence, define and prioritize relevant data sets across products and markets
b. Plan and lead Clinical studies (i.e.: Phase 4): drive strategy, hypothesis, research questions, sample, statistical plan and analysis
c. Generate real life experience performing clinical evidence procedures according to clinical evaluation practices used in the industry.
d. Collect and update clinical data: literature search, incident report databases, customer's feedback
2) Supervise the Medical Information function ensuring the alignment of Medical Information response documents to global / regional / local labelling and licensing agreements for all the countries Brighter supports.
3) Be the scientific / medical external representative of the company
a. Supporting the generation of relevant information and communication for Health Care Professionals (Physicians, Nurses, Pharmacists) and Patients
4) Provide Medical support to Commercial counterparts
a. Review and approve promotional and marketing materials from the point of view of Brighter's clinical claims
b. Help to identify real works hurdles in the Diabetes care
c. Expand understanding of patients and health care professional's perspective in the international arena beyond Sweden
d. Help to perform Diabetes care major Gap analysis 2025
5) Teamwork with Regulatory, Medical Information, Commercial, Marketing, Communication, Medical team (diabetes nurses, physicians etc.), Technical Writer, Customer service, External Advisors.
Your profile:
The following experience/knowledge is strongly meriting:
• Training in medical management, finance and quality assurance are a plus.
• 5 or more years of Industry experience (Clinical Sciences and/or management experience in the medical, pharmaceutical or biotech-industries.
• High level of Proficiency in both written and spoken English, Swedish is a plus
• Good knowledge in technology for diabetes management including different glucometer devices, flash monitoring, CGM and insulin pumps.
• At least 3 years' experience in a managerial capacity managing clinical programs and clinical professionals in a cross functional product development setting.
• Experience of planning and performing clinical evaluations according to MEDDEV 2.7/1 rev 4 and other relevant frameworks
• Previous experience preferred in the application of therapeutic and device knowledge to development of clinical evaluation reports
• Medical Affairs and Pharmaceutical Industry experience preferred
• Extensive experience in conducting and performing systematic literature searches, reviews according to PICO strategy and appraisal of the scientific data
• Proven experience in development and management of clinical studies
• Strategic mindset, with the ability to contribute to strategy development on both national or regional level, proven leadership and excellent communication skills
• A strong advocate and interest for the latest innovation, technology and remote patient monitoring devices related to diabetes.
• Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report
• Proficiency with computer and software applications and comfortable with statistical analysis.
A suitable academic background is a University degree (MD, PhD) in Medicine or Medical Science is required.
You are fluent in English, both written and oral. As Brighter is a truly international company you don 't need to speak Swedish for this position.
This role is ideal for a person who is interested to create a bridge between science and general population, thus solving existing health problems.
Our offer:
The company offers you an exciting role in an innovative environment. You will be a part of a company in strong growth with values that engages every employee.
If you fulfil these criteria and are ready for a challenge, please submit your application online. We will not be able to handle any applications via e-mail due to GDPR.
Your consultant, Thomas Lindquist at Talentor Sweden,
thomas.lindquist@talentor.com, will contact you promptly upon receipt.
Publiceringsdatum2020-06-16Så ansöker duSista dag att ansöka är 2020-06-28
Klicka på denna länk för att göra din ansökanFöretagTalentor Sweden AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Talentor Sweden AB (org.nr 556659-7828)
Arbetsplats Brighter AB
Jobbnummer 5266433
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