Assoc Dir Scientific Communications in Westlake Village, California at Arcutis Biotherapeutics Inc

The Associate Director, Scientific Communications will be responsible for the execution of medical affairs functions including, but not limited to, medical review of promotional and non-promotional materials, medical communications and medical information activities. In this critical role, you will provide medical and scientific expertise to ensure that all promotional materials are accurate, balanced, substantiated by clinical evidence, referenced, and fully compliant with regulatory requirements (FDA OPDP, EMA, and other global standards)

They will develop and manage timelines to support efficient planning, review, referencing and tracking of data/material and establish strong partnerships with internal cross-functional stakeholders. She/He will work closely with key stakeholders to ensure expert input and overall quality of resources, materials and communications, including, but not limited to promotional and non-promotional materials, scientific platforms, external communications, Medical Affairs website, medical science liaison presentations, training materials, and medical information documents.

Roles & Responsibilities

1. Provide input into and coordinate the medical review of materials through the Medical andPromotional Review Committee process.

1. Conduct comprehensive medical and scientific reviews and context review of promotional and non-promotional materials via theMedical andPromotional Review Committee processes.Ensure all claims are truthful, non-misleading, fair-balanced, and adequately supported by clinical data and approved product labeling.

1. Collaborate closely with cross-functional teams including Marketing, Medical Affairs, Legal, Regulatory Affairs, and Commercial to provide timely medical input and resolve review issues.

1. Identify potential regulatory risks and provide strategic recommendations to achieve compliant solutions.

1. Maintain deep knowledge of product data, including clinical trial results, safety profiles, and real-world evidence.

1. Participate inMedical and Commercial Office hours and promotional review committee (PRC) meetings and provide clear, concise written and verbal feedback.

1. Contribute to the development and continuous improvement of review processes, templates, and training materials.

1. Effective management of external agencies and budget (i.e.Medical Reviewers)

1. Support global and regional teams on promotional materials as needed.

1. Stay current with evolving regulations, guidelines (e.g., FDA Draft Guidance, PhRMA principles), and industry best practices related to pharmaceutical promotion.

1. Contribute to and follow company policies procedures, SOPs and guidance documents that are relevant to the conduct of job duties and responsibilities.

1. Other duties that may be assigned include but not limited to: Execute on strategic Medical Affairs initiatives in support of department priorities,as assigned by management;including but not limited to,Collaboratewith internal subject matter experts to develop standard response documents, FAQs, medical science liaisonpresentations and resources;Conference booth content and execution.

Education & Licenses and Experience

Advanced degree in biomedical sciences required (i.e., PhD, PharmD, MS) and 5 years of related experience, or the equivalent combination of education and experience. Experience in the areas of atopic dermatitis and psoriasis is preferred.

Competencies & Skills

• Excellent strategic planning, organizational, and communication skills
• Ability to analyze complex issues to develop relevant and realistic plans,programsand recommendations
• Excellent verbal and written skills, allowing for open and effective dialogue
• Ability to influence without authority, lead change and manage resistance to change
• Understand the importance of meeting corporate goals
• Experience with pre-launch, launch, and post-launch activities
• Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues
• Ability to recognize and cultivate appropriate collaborative opportunities with key internal stakeholders and external partners
• Strong presentation and teaching skills
• Proven skills to manage external staff and agencies
• Strong conflict resolution skills, solutions oriented
• Strong interpersonal skills
• Ability to learn and convey clinical and non-clinical technical information effectively
• Ability to work independently and function in a rapid paced, high pressure environment
• Proficient in the use of business productivity software (Excel, Word, PowerPoint, etc.)
• Travel may be required up to 20% of time worked

Why Join Us?

Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

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