Assoc Dir Scientific Communications

About the Role

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.

Responsibilities

• Provide input into and coordinate the medical review of materials through the Medical and Promotional Review Committee process.
• Conduct comprehensive medical and scientific reviews and context review of promotional and non-promotional materials via the Medical and Promotional Review Committee processes.
• Ensure all claims are truthful, non-misleading, fair-balanced, and adequately supported by clinical data and approved product labeling.
• Collaborate closely with cross-functional teams including Marketing, Medical Affairs, Legal, Regulatory Affairs, and Commercial to provide timely medical input and resolve review issues.
• Identify potential regulatory risks and provide strategic recommendations to achieve compliant solutions.
• Maintain deep knowledge of product data, including clinical trial results, safety profiles, and real-world evidence.
• Participate in Medical and Commercial Office hours and promotional review committee (PRC) meetings and provide clear, concise written and verbal feedback.
• Contribute to the development and continuous improvement of review processes, templates, and training materials.
• Effective management of external agencies and budget (i.e. Medical Reviewers).
• Support global and regional teams on promotional materials as needed.
• Stay current with evolving regulations, guidelines (e.g., FDA Draft Guidance, PhRMA principles), and industry best practices related to pharmaceutical promotion.
• Contribute to and follow company policies procedures, SOPs and guidance documents that are relevant to the conduct of job duties and responsibilities.
• 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, Collaborate with internal subject matter experts to develop standard response documents, FAQs, medical science liaison presentations and resources; Conference booth content and execution.

Qualifications

• 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.

Skills & Competencies

• Excellent strategic planning, organizational, and communication skills.
• Ability to analyze complex issues to develop relevant and realistic plans, programs and 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.).
• Experience in the areas of atopic dermatitis and psoriasis is preferred.
• Travel may be required up to 20% of time worked.