Regional Liaison Oncology Associate Director

**Job Description**:
Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.
- The Regional Liaison is a broad role encompassing all aspects of regulatory strategy and execution to support countries in the region, giving strategic and operational oversight within multiple areas including clinical, Chemistry, Manufacturing, and Controls, quality, safety and labeling;
- Development of regulatory strategy for their assigned products in Oncology, in order to optimize label and obtain shortest time to approval by regulatory agencies in Latin America countries;
- Provide expert advice to multiple Product Development Teams and countries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug;
- Supports leadership teams to provide regionally focused strategic inputs to product development across the region aiming faster product approvals and early patient access;
- Works on product strategies for new assets as well as life cycle management;
- Independently manages projects within the Oncology Therapeutic Area, functioning as the single, accountable, point of contact on those projects;
- Primary point of contact, acting as an important bridged between country and headquarter integrating multiple functional areas in Development, Commercial, Quality/Manufacturing;
- Coordinate interactions with foreign agencies through Country Regulatory Affairs to boost their interactions and provide strategic direction across multiple countries simultaneously;
- Supports regulatory topics on in vitro diagnostic, including companion diagnostic and combinational products and medical devices;
- Shares experience across the group and within the broad Regulatory Affairs International community to set up common regulatory approaches;

**Educational requirements**:

- Healthcare professional (pharmacist, MD, biochemistry) or Master’s degree in biological science, chemistry or related discipline;
- Regulatory Affairs expertise in pharmaceutical companies;
- Project management qualification is a plus;
- Proficient in English (Fluent English is a must);
- Fluent in Spanish and/or Portuguese is a plus;
- Knowledge in clinical concepts focused in Oncology.

**Skills**
- Communication skills (written and oral);
- Project management;
- Collaborative skills with an ability to work both proactively and reactively in a timely manner in a dynamic fast-paced environment with a “getting things done” spirit;
- Ability to assess, prioritize, and execute multiple projects, tasks, and/or assignments;
- Problem-solving;
- Negotiation;
- Flexibility and adaptability;
- Business Acumen;

Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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