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Manager, Medical Core Content - Rare Disease
Manager, Medical Core Content - Rare DiseaseMaryland Staffing • Annapolis, MD, US
Manager, Medical Core Content - Rare Disease

Manager, Medical Core Content - Rare Disease

Maryland Staffing • Annapolis, MD, US
13 days ago
Job type
  • Full-time
Job description

Manager, Medical Core Content

The Manager, Medical Core Content is a team-level operational role responsible for the development, maintenance, and day-to-day quality assurance of all core scientific and medical content for the relevant therapeutic area. This role focuses on the execution and production of scientific assets, ensuring they accurately reflect clinical data, adhere to the core scientific narrative, and are compliant with all internal and external regulations. This position reports directly to the Associate Director, CNS Scientific Communications.

Key Responsibilities Include :

  • Core Content Development
  • Under the guidance of the Associate Director, Medical Communications, draft and maintain high-priority, foundational scientific communication core materials, including :
  • Core Disease State Decks
  • Core Field Materials
  • Medical Publications
  • New Data Reporting
  • Medical Information Content Generation
  • Scientific Accuracy and Consistency
  • Ensure all content adheres to the approved core scientific narrative and lexicon, accurately reflects clinical trial data, and maintains consistency across global materials
  • Maintain content repositories and ensure version control and accessibility for global teams
  • Utilize platforms like Veeva Vault, to manage content lifecycle and Medical Review submissions
  • Track and report content usage and effectiveness, providing insights for optimization
  • Data Integration
  • Collaborate with Clinical Development and Research teams to integrate new data from clinical study reports or publications into existing core content
  • Cross-Functional Collaboration
  • Act as key support resource for the Field Medical Affairs team, managing the content repository and version control for field-facing materials
  • Partner with external medical writing agencies, providing operational input and feedback, reviewing drafts for scientific accuracy, and ensuring deliverables align with project timelines
  • Ensure all content creation and review processes adhere to internal Standard Operating Procedures (SOPs), Good Publication Practices (GPP), and global regulatory guidelines
  • Medical Information Content Generation
  • Develop, review, and maintain high-quality, scientifically accurate medical information content for relevant therapeutic area products, including standard response letters, FAQs, and global core content
  • Ensure all content complies with regulatory, legal, and medical standards, and is aligned with product strategy and scientific messaging
  • Collaborate cross-functionally with Medical Affairs, Regulatory, Legal, and Commercial teams to ensure consistency and accuracy of medical communications
  • Support the global-to-local adaptation of core content for use by regional and affiliate medical teams
  • Serve as a champion for Medical Review / Promotional review processes for materials
  • Manage content lifecycle processes, including version control, periodic review, and archiving in content management systems (e.g., Veeva Vault)
  • Partner with external vendors and internal stakeholders to ensure timely and efficient content development and approval
  • Monitor scientific literature and product data to ensure content reflects the most current evidence and clinical guidance
  • Contribute to the development and implementation of content governance frameworks and best practices
  • Provide training and guidance to internal stakeholders on the appropriate use of medical information content
  • Consider technology and AI to support workflow improvement

Qualifications

  • Education and Experience :
  • Advanced scientific degree is strongly preferred (PharmD, MD, PhD, or equivalent) with expertise in Neuroscience or a related field
  • Minimum of 4+ years of applied experience in Medical Affairs, Scientific Communications, Medical Writing, and / or medical information within the pharmaceutical or biotechnology industry
  • Proven experience in the development and writing of core medical affairs content (e.g., scientific decks, disease state materials)
  • Experience working with medical writing agencies and managing content projects against strict timelines
  • Skills and Competencies :
  • Ability to interpret complex scientific data and translate it into clear, concise, and scientifically accurate communication materials for a professional medical audience
  • Strong focus on accuracy, consistency, and quality assurance in content creation and version control
  • Demonstrated ability to manage multiple content projects and deadlines independently within defined scope and guidance
  • Strong verbal and written communication skills to collaborate effectively with internal cross-functional partners and external vendors
  • Foundational understanding of the principles governing scientific and medical communications, including GPP and regulatory compliance requirements
  • Competencies

  • Accountability for Results
  • Strategic Thinking & Problem Solving
  • Patient & Customer Centricity
  • Impactful Communication
  • Respectful Collaboration
  • Empowered Development
  • Compensation : $117,027.00 - $175,030.00, plus incentive opportunity

    Company Benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

    If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com).

    Statement Regarding Job Recruiting Fraud Scams : At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and / or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website. Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at : 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at : https : / / www.ic3.gov, or your local authorities.

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    Manager Rare Disease • Annapolis, MD, US

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