About this Coordenação de Pesquisa Clínica e Bioequivalência - Divisão de Farmacêuticos Estabelecidos (EPD) - São Paulo/ SP role at Abbott
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of.
Benefits such as Medical and Dental Assistance, Life Insurance, Private Pension Plan, Medication Subsidy, Discount on Abbott stock purchases, among others.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
We offer flexible work policies that allow a healthy balance between personal and professional life
We invest in the development of our employees through training andgrowth opportunities
We foster an environment where every voice is heard and valued
The Opportunity
This position works out of our São Paulo site in the Established Pharmaceuticals Division.
We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
What You’ll Do
Provide accurate planning assumptions (budget and timelines) for proposed clinical programs/studies
Work on single country studies which include Phase III, IV, and complex BE studies.
Also, can be assigned PMOS and IIS studies as needed
Lead the operational feasibility assessment of proposed clinical studies
Plan, execute and close approved clinical studies according to the agreed budget and timeline and in accordance with applicable internal and external standards (Abbott OEC, Policies and Quality System, ICH&GCP and local regulations)
Coordinate Abbott internal disciplines (as chair of Abbott Clinical Study Team), CRO team and insourced staff where applicable
Select CRO and/or insourced staff
Apply Project Management tools within Abbott environment
Ensure that the study plans reviewed and followed
Lead Risk and Issue Management (where needed this can include contact with external stakeholders, e.g. Clinical Sites, Regulatory bodies, KOL).
Perform Oversight on CRO, vendors and Abbott internal disciplines
Report progress to Abbott the functional lead
Safety reporting is completed as per the SOPs and plans
Participate in update meetings with I&D, medical affairs team as needed
Maintain budget for the assigned studies and support functional leads for overall budget management
Ensure study and clinical sites are inspection ready. Support and participate in the preparation and execution of internal audit or external inspection, as well as the relevant CAPA afterward
Foster a culture of continuous improvement in clinical study operations, including implementation of lessons learned
May be assigned certain simple special projects to work upon
Mentoring Role for CTAs.
Support other activities as per local/regional requirements
Required Qualifications
M. Pharm, /B Pharm/ MSc/BSc Medical, Pharmacy or life sciences degree (or equivalent)
Ability to work in a complex cross-cultural environment, with stakeholders all around the world
Advanced project management skills
Ability to make effective decisions based on good science and data in compliance with regulatory requirements and risk assessments
Excellent knowledge of development of pharmaceutical products
Excellent communication skills
Excellent clinical reasoning skills, with the ability to independently assess and conclude on published and in-house data related to pharmaceutical products and EPD’s therapeutic areas
Excellent English language skills, particularly in written form
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Medical & Scientific Affairs
DIVISION:
EPD Established Pharma
LOCATION:
Brazil > Sao Paulo : Building 1
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
