bioM?rieux BV
Location
São Paulo, SP | Brazil
Job description
Job Description
The Position
The Senior Medical Manager will be in charge of biosimilars and established products (EP), managing products that are mostly related to diseases that affect women as breast cancer and some rheumatologic/immunologic diseases. (S)he will report to the Country Medical Director working in a matrix organization with other Medical Advisors, Field Medical and Medical Services teams.
Responsibilities
The BioS Senior Medical Manager is responsible for oversight on all aspects of local Medical Affairs (MA), including:
Country Medical team focusing on local Organon Medical strategy for biosimilars, with a heavy emphasis develop Regional and Global Medical strategy.
Supervise the established products strategy and promotional materials.
Building relationships with internal and external stakeholders, including scientific leaders, medical societies e patient associations.
Strategic planning of scientific communication and continuous medical education.
Providing strategic medical and scientific advice, working in close collaboration to business units, Market Access functions, regulatory affairs, communication and others as required, including input into Health Economics.
Providing insights for company-sponsored local or global studies, review and approval of local study protocols and Investigator Initiated Study (IIS) protocols.
Ensuring compliance with all applicable country and global policies, including local regulation.
Developing relationships with regulatory authorities in collaboration with the local head of regulatory.
Overseeing inspections and answering inquiries by health authorities and ethical committees in conjunction with Regulatory and PV.
Orchestrating regional input for medical priority setting and co-sponsoring the regional Medical Affairs planning team to have bi-directional communication with Headquarters.
Required Education, Experience, and Skills
Medical degree, PhD in health sciences, Pharm D or equivalent.
Minimum 5 years of experience in Medical Affairs, MSL Sr and/or Clinical Development.
Demonstrated effective organizational skills, including the ability to set goals and align priorities.
Intermediate/Advanced English level
Preferred Education, Experience, and Skills
Previous experience with biosimilars and or biology products for rheumatology/Gastro/dermatology is considered a differential.
Strong understanding of the compliance environment in which Medical Affairs functions.
Business acumen, ethics and credible reputation with the external scientific community.
Knowledge of interventional/non-interventional clinical studies and drug development.
Ability to simplify and convey complex concepts and strategies, orally and in writing, and conduct/facilitate meetings with strong presentation skills.
Demonstrated creativity and effectiveness in addressing strategic challenges, an entrepreneurial mindset, and the capability of thinking out of the box and taking measured risks.
Ability to understand issues across a global affiliate network and contribute relevant insights as appropriate.
Comfortable managing a matrix organization.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at [email protected] .
Search Firm Representatives Please Read Carefully
Organon LLC , does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID: R523545
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