Manager, US Medical Affairs- Cambridge- MA

Manager, Medical Reviews, US Medical Review

Job Summary

The Manager is a Cambridge-based member of the US Medical Affairs team in the Rare Diseases therapeutic area. The mission of this team is to support the company by functioning as internal experts in genetic diseases, our therapies, and in helping Health Care Professionals and Payers optimize patient care and treatment outcomes through evidence-based decisions. We feel this is best accomplished through the generation, interpretation and communication of accurate clinical and scientific information. The manager plays a key role in this mission by providing the scientific leadership and review in disease-specific area(s) and reports to the Head of U.S. Medical Affairs, Rare Diseases.

The Manager will lead a series of critical activities that affect the outcome of our primary mission. S/He will have a national scope and will be responsible for promotional review and a series of focused Medical Affairs projects within the US/North American Rare Medical Affairs group. The Manager will establish and maintain collaborative medical and scientific relationships with key internal staff, including but not limited to Legal, Compliance, Medical, Medical Communications, MEdical Information, Clinical Research, Regulatory, Science, Marketing, Sales, Commercial Operations, and Patient and Product Services, while maintaining full compliance with all relevant company, industry, legal, and regulatory requirements.

The primary role of the Manager will be to review and evaluate the medical and scientific accuracy of various promotional and non-promotional materials including but not limited to slide sets, sales aids, dossier updates, training materials and medical response letters. In this highly collaborative and fast paced role. The Manager will further have an opportunity to act as a key strategic partner with various groups including but not limited to Legal, Regulatory, Marketing and Compliance. S/he will assist with various Medical Affairs related projects as needed within the Medical Affairs group and across the Business Unit, unrelated with the promotional review activities but leveraging knowledge of the disease areas and therapeutic products we support and our field teams impacts in the US. Specific training and skills in the planning, capturing, and analysis/interpretation of Medical Affairs metrics data will be provided. Skills in the practical measurement and presentation of this data will be gained through this position and will focus on championing future development.

Major Duties and Responsibilities

* Promotional/non-promotional review for assigned products in the Rare Disease BU, which include major assets, sound medical advice that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and COMPANY policies for advertising and promotion of prescription drug products and biologics

* Consultative support to MA project teams for issues/strategies relating to continuity between development plans and commercial objectives

* Provision of competitively positioned promotional materials that comply with applicable FDA and corporate regulations, policies and guidance

* Acting as an internal expert on FDA regulations governing the promotion of assigned products.

* Analyze whether clinical and non-clinical promotional claims are supported

* Provide insight, judgment and sound decisions on promotional programs and tactics for assigned products.

* Maintain a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry and communicate relevant information appropriately to stakeholders.

* Provide input on promotional implications of proposed clinical study designs, and serve as a MA liaison with Sanofi Genzyme Rare Clinical Development.

* Advise on the development of US labeling to ensure support for anticipated promotional messages and claims.

* Develop/maintain an in-depth understanding of labeling for assigned company and competitor products and the subsequent translation of that knowledge into the development of promotional materials.

* Ensure application of key learning's across assigned brands, ensuring alignment of development and commercial objectives

* With limited supervision, recommend appropriate actions for proposed advertising and promotion sometimes with little or no precedent

* Other duties and responsibilities may be assigned

Job Type: Full-time

Competencies & Capabilities

* The individual will require strong verbal and written communication skills

* Strong interpersonal skills; good listening skills

* Demonstrated ability to influence and persuade others

* Demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions.

* This position must be able to evaluate and articulate regulatory risk to members of legal, regulatory, medical information, medical affairs, and the commercial organization

* This position is expected to routinely influence and persuade others on difficult and complex issues that have the potential for significant reputational and financial impact on the organization.

Qualifications

* Degree in a biological or health care scientific discipline, including a PharmD, MD, or PhD

* Professional experience with pharmaceutical industry medical/legal review process for prescription drug advertising and promotion in compliance with applicable FDA laws, regulations and guidance documents

* Demonstrated understanding of the drug development process

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG #LI-GZ

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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