Business Analyst SME (Hybrid/ On-site)

We are seeking a highly experienced Senior Subject Matter Expert (SME) in the content supply chain within the life sciences industry to assist in delivering the BOFT Content GenAI program. This individual will act as the Business Solution Analyst and Project Manager and will be responsible for delivery from the Informatics side. Proven experience in the transformation of content operations within the life sciences industry and the ability to be onsite at the client office in San Francisco is essential.

The Marketing and Content Operation involves the below:

Marketing commercial pharma content management" refers to the process of creating, organizing, distributing, and managing all marketing materials related to pharmaceutical products within a commercial setting, ensuring that content is accurate, compliant with regulations, and tailored to specific target audiences like healthcare professionals and patients, while strategically promoting the product to drive sales.

Key aspects of commercial pharma content management:

• Compliance:

Strict adherence to regulatory guidelines set by agencies like the FDA, ensuring all marketing materials are truthful and accurate regarding drug efficacy and safety information.

• Target Audience Segmentation:

Creating different content formats and messaging to effectively reach various healthcare professional segments based on their specialties and needs.

• Multi-channel Distribution:

Utilizing a variety of channels like digital platforms, email campaigns, medical conferences, sales rep interactions, and websites to deliver targeted content.

• Content Creation:

Developing diverse content formats including product information, educational materials, case studies, clinical data summaries, videos, infographics, and thought leadership articles.

• Modular Content Approach:

Creating reusable content components that can be easily adapted and combined to generate customized materials for different audiences and situations.

• Content Governance:

Establishing clear processes for content review, approval, and version control to maintain accuracy and consistency across all marketing materials

Key Responsibilities:

• Co-acting with the BA as Informatics Product Owner for the BOFT Content GenAI initiative.
• Managing stakeholders and collaborating with marketing and operations teams.
• Coordinating teams and service integrators for:

o Content authoring tool implementation, integration, and pilot.

o PRC automation.

o TBD DAM enablement for pilot.

• Reporting progress to senior leadership and removing roadblocks.
• Coaching Roche resources to upskill them with domain knowledge.

Required Experience and Skills:

• Deep understanding of marketing and content operation processes.
• Broad overview of how content supply chains operate in various life sciences companies and what good practices are.
• Proven experience in the transformation of marketing content supply chains within the life sciences industry.
• Strong senior stakeholder management skills.
• Strong project management and coordination of delivery with service integrators.
• Hands-on approach to removing roadblocks and ensuring delivery.

Expectations:

• The role will meet challenging deadlines and bring proper domain expertise to the organization.
• Work in tandem with a BA from Informatics, who lacks deep domain knowledge.
• The expectation is that after the first half of 2025, the BA will take over this role.

Additional Notes :
content approval process within the pharmaceutical industry

The content approval process within the pharmaceutical industry is a structured and highly regulated procedure designed to ensure that all promotional materials, medical communications, and other related content comply with legal, ethical, and scientific standards. The process typically involves several key steps and requires collaboration between different departments, including regulatory affairs, legal, medical, and marketing teams. Here is an overview of the general process:

1. Content Creation

• Drafting: The content, whether it s for promotional materials, advertisements, educational brochures, or scientific publications, is first created by the relevant teams (marketing, medical affairs, etc.). The content is usually based on scientific data, product information, and the company s strategic objectives.
• Initial Review: At this stage, content is reviewed internally for accuracy, consistency with brand messaging, and alignment with strategic objectives. If it's a medical piece, the medical affairs or clinical team ensures that it reflects the most up-to-date scientific data.

2. Internal Review (Cross-Functional Teams)

• Medical Review: The medical affairs team ensures that the content is scientifically accurate and that any claims made are supported by evidence. They also check for compliance with ethical guidelines, such as making sure that content does not promote off-label use of a drug or make unsupported claims.
• Regulatory Review: The regulatory affairs team ensures that the content complies with national and international regulations (e.g., FDA, EMA) and that it adheres to any relevant pharmaceutical guidelines.
• Legal Review: The legal team reviews the content to ensure that there is no potential for legal issues, such as false advertising or violation of intellectual property rights. This includes confirming that all trademarks and patents are correctly used.
• Marketing/Branding Review: The marketing and branding teams ensure that the content aligns with the company's overall branding and marketing strategies. They also review the messaging to ensure it resonates with the target audience.

3. Compliance with Industry Codes and Guidelines

• Content must comply with local and international industry standards and codes of conduct, such as:
• FDA Regulations (U.S.): Content must adhere to FDA rules on drug advertising and promotion.
• EMA Guidelines (Europe): Similar guidelines are in place for pharmaceutical marketing within the European Union.
• PhRMA Code: The Pharmaceutical Research and Manufacturers of America (PhRMA) has a code of conduct that governs interactions between pharmaceutical companies and healthcare professionals.
• Other Codes: Codes like the ABPI (Association of the British Pharmaceutical Industry) Code of Practice in the UK, and the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) Code of Practice globally, must also be followed.

4. Approval by Senior Leadership

• Once the content has passed through all the necessary internal reviews, it is often submitted to senior management (such as the Brand/Marketing Directors, Medical Affairs leadership, etc.) for final approval.
• In some companies, this step may involve specific review committees that are responsible for overseeing all content prior to dissemination.

5. External Review (if applicable)

• Regulatory Authorities: In some cases, especially for high-risk promotional content (e.g., for new drugs or major claims), content may need to be submitted to health authorities (e.g., FDA, EMA) for approval before it can be publicly distributed.
• Third-Party Consultants: Some companies use external experts or consultants to review content, particularly if it s a highly specialized topic, such as clinical trial results.

6. Final Approval and Distribution

• After all the approvals have been obtained, the content is cleared for release. It can then be distributed through the appropriate channels (e.g., print, digital, social media, or direct communication with healthcare professionals).
• Any necessary training for sales representatives or other employees who will use the materials may also be conducted at this stage.

7. Post-Approval Monitoring

• Ongoing Monitoring: After content is released, the company monitors how it is being received, and whether there are any issues or regulatory concerns that arise. This may involve tracking feedback from healthcare professionals or monitoring social media for reactions.
• Compliance Audits: Periodic audits ensure that the content continues to comply with applicable regulations and company policies.

Key Considerations in the Pharmaceutical Content Approval Process:

• Transparency and Accuracy: Claims about efficacy, safety, and side effects must be accurate and based on robust scientific evidence.
• Regulatory Adherence: Each market (e.g., U.S., EU, Asia) has its own regulatory standards that need to be strictly followed.
• Ethical Standards: Content must adhere to high ethical standards to ensure patient safety and avoid any form of misleading information.

This rigorous and multi-step process is necessary because of the high stakes involved in pharmaceutical marketing, where misinformation or regulatory violations can result in severe consequences such as legal penalties, loss of public trust, and harm to patients.