Medical Affairs Review and Approval Expert
il y a 1 jour
Medical Affairs Review and Approval Expert
Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
HOW WE IMPACT PATIENTS
We contribute to transforming the lives of patients through science. We lead the medical conversation partnering broadly to generate scientific evidence. In this role your will be at the heart of science focused on our breakthroughs that transform patients´ lives
HOW YOU WILL CONTRIBUTE
The Medical Affairs Review and Approvals Expert (MARA) plays an essential role and is primarily responsible for the medical review and approval of all promotional, educational ( including patient support materials) and digital multi-channel materials across Categories to ensure scientific validity and compliance with local regulations and global and local procedures.
This position comes with high responsibilities and aims to minimize compliance risks for the company while being the go-to-person for the approval of new materials.
The key responsibilities in this role include:
- Review and/ or approval of promotional and non-promotional materials across Categories in compliance with local regulations and global and local procedures through the relevant systems (MLR review and approval in GCMA).
- Understands the different channels & content approaches and their value to Pfizer
- Can effectively use the tools/technology available for their role
- Ensure scientific accuracy of claims, references and translations and ensure alignment with local product label.
- Is a key contributor to ensure local content promotional compliance
- Collaborates closely with the relevant cross functional colleagues across Categories to ensure a streamlined approach, including In-Country-Signatory, Medical Affairs Scientist (MAS), the Medical Affairs Data Expert (MADE) and commercial and content generation stakeholders
- Acts with integrity whilst evaluating and managing risk
- Knows and understands Pfizer Policy & Compliance
WHAT WE EXPECT
Qualifications:
- Master degree in life science
- Ability to interpret scientific publication and scientific data
- Understanding of clinical trials and observational (RWD/RWE) studies
- Strong presentations skills and ability to deliver scientific messages
- Knowledge of the relevant and applicable Codes of Practice and regulations
- Fluent in Dutch/French and English
- Pharmaceutical industry experience
- Process improvement skills/experience
Competences:
- This role requires strong collaboration and communication skills.
- Innovative and growth mindset, solution driven and quality orientated
- Ability to work independently with high accountability
- Ability to maintain focus and manage multiple projects
WHAT YOU CAN EXPECT
At Pfizer, we invest in creating an environment which unleashes the power of our people. Some of our key drivers:
Diversity, Equity and Inclusion - Everyone has something to offer. We believe that a diverse and inclusive organization is crucial to building a successful organization. Pfizer is committed to celebrating this in all its forms ensuring we are as diverse as the patients and communities we serve.
When you grow, We Grow - All colleagues are empowered to unleash their full potential, delivering on our company purpose through non-linear career paths, made of a diverse set of experiences.
Health & Wellbeing
- We empower our colleagues to better care for themselves and make new investments to help them manage their mental and physical well-being. Ensuring an environment where colleagues can unleash their power and bring joy at work is one of our focus areas.
OUR OFFER
At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Pfizer's open-door policy is an integrated part of our culture across all levels of seniority.
We offer possibilities for working from home (up to 3 days per week) and flexible working hours.
Competitive salaries and benefit packages : meal vouchers, DKV hospitalisation, outpatient, dental, pension plan, phone, public transport reimbursement,
Unparalleled opportunities for career growth: trainings, possibilities for internal mobility, temporary assignments
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing f
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