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The Position

Objectives and Scope of Position:

-The role is a key strategic medical partner requiring therapeutic area expertise and clear business understanding to identify and address the relevant medical needs of clinical practice, to successfully support the optimal use of Roche products.

-He/she links affiliate to Global Medical Affairs objectives to deliver on data generation, knowledge exchange / data communications, and to lead TAE engagement in a scientific manner.

-The role acts as a guardian for high standards of compliance, ethics, and safety of Roche products, putting patients at the center of his/her actions

Primary Responsibilities and Accountabilities

1. Development and management of the medical plan

-Identify local data gaps, local study/research protocol design, study/research planning (including budget)

-Align the local medical plan with the local marketing, disease area strategy and global medical plan, under supervision of Medical Affairs Leader

-Congress overview and guidelines development

2. Be the medical expertise to bring value for cross functions

-Offer expert opinion aligned with global medical recommendations on scientific medical information to identify and develop effective peer-to-peer relationships to execute our product strategies, while holding high ethical standards, compliance to Roche SOP and local/international regulations

-Research, collate, present and offer data insights related to the dedicated disease area and product(s)

-Manage the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.

-Manage Medical Information activities in accordance with regional/local model, referencing global standard responses

-Manage publication related activities according to Roche Policy and SOPs

-Develop a customer centricity culture, making sure promotional/medical/scientific communications address HCP needs and optimize patient benefit and safety while keeping a fair balance and compliance with regulations and SOPs

3. Clinical programs management

-Receiving ISTs, championing the review of ISTs within the company, and following-up with investigators, in accordance to all local laws and regulations

-Supporting Roche sponsored study planning and execution including enhancing the site's performance and quality

-Support site feasibility assessments, site development plan, recruitment, retention of patients enrolled in trials and enhancement of site management

-Serving as the scientific bridge and lead CUP/PAA/LAM local operation.

4. TAE engagement plan and execution

-Maintain regular contacts with investigators for key studies

-Identify and develop scientific relationship with external TAEs/ experts who are qualified sources of insight and advice

-Ensure that all activities towards external experts / TAEs are harmonized across the affiliate

-Share Best Practices across customers to facilitate improved patients outcome

-Planning and execution of relevant scientific advisory boards and expert meetings

5. Others

-Inform Local Safety Responsible person of safety issues according to Roche safety requirements scientific support and follow-up on product safety issues

-Support regulatory activities, including preparation of relevant data for new products/indications application and label updates

-Provide medical/scientific support and training for internal staff or vendors

-Support and collaborative work with pharmaco-economic and access teams, providing relevant efficacy and safety data on dedicated products Act as medical expert for requests from external organizations, e.g.. media (via PR department)

-Design and implementation of congresses booth and non promotional symposia and selection of recipients of travel sponsorship

-Evaluation of incoming requests of grants/sponsorships and proceed them.

-Budget management for LMA studies and Medical activities.

- Define grant support prioritization strategy and execution

Professional and Technical Requirements

Education/Qualifications: Medical or PhD/PharmD degrees preferred. Other graduate health science degrees, or equivalent with strong proven therapeutic area experience considered.

Minimum: Master degree of Medical/Pharmacy/Biology related

Strongly desired:

Experience, Skills, Knowledge

1. Professional experience within the pharmaceutical industry desirable but not mandatory

2. Knowledge of the overall drug development process relevant to pharmaceutical/biotechnology organizations

3. Experience in development and implementation of clinical trials

4. Experience in the principles and techniques of data analysis, interpretation, and clinical relevance

5. Experience of writing clinical publications and delivery of scientific presentations

6. Relationships with external TAEs, other thought leaders, and external organizations is strongly preferred

7. Strategic thinking

8. Leadership skills

9. Analytical Skills

10. Results orientation

11. Communication, interpersonal and networking skills

12. Negotiation skills

13. Presentation skills

14. Knowledge in data analysis and statistics

15. Knowledge of relevant therapeutic area

16. ICH, GCP and local regulations

17. Appreciates the diversity of working with multifunction teams

18. Knowledge of drug discovery & commercialization processes.

19. MS office literate

20. Fluent English language knowledge, written and verbal

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Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.