Senior Manager Scientific Affairs ALS

Shionogi Inc. in; Florham Park (NJ); On-site; USD 145,000 - 175,000; Full time

Job summary

Shionogi Inc. in New Jersey is seeking a Senior Manager, Scientific Affairs ALS (Finance) to support Scientific Affairs programs for marketed and late development products with a Rare Diseases focus. The role ensures scientific and regulatory compliance and collaboration with executives.

Responsibilities include overseeing Medical Information data analysis, SOPs, SRLs, and publications processes; coordinating BOAST/WIKI operations; and supporting CI/MI projects. Travel up to 5–10% as needed.

Qualifications

• Advanced degree in Life Sciences (PharmD or PhD).
• 3–5 years of industry experience in pharma, medical device or biotech.
• Rare disease experience; Neuroscience preferred.

Responsibilities

• Oversee Medical Information data analysis, tracking FAQ trends and ensure materials comply with policies.
• Lead in product safety activities related to medical information with PV and QA.
• Support timelines and coordination for scientific communications and publications.
• Coordinate creation of scientific presentations and materials as directed.
• Plan and lead operation of BOAST platform and WIKI, ensuring updates and accessibility.
• Audit BOAST content semi-annually with Field Medical Director and manage external vendor.
• Support CI/MI project deliverables and disseminate reports to HQ personnel.
• Serve as internal SME on disease state and clinical data impacting patient care.

Skills

Stakeholder relations

Strategic thinking

Regulatory compliance

Leadership

Communication

Project management

Travel readiness

Education

Advanced Life Sciences degree (PharmD or PhD)

Job description

Senior Manager Scientific Affairs ALS (Finance)

Overview

The Senior Manager, Scientific Affairs ALS will be responsible for supporting the execution of Shionogi Inc.'s Scientific Affairs programs in the US that support marketed and late development products and compounds with a focus on Rare Diseases. These Scientific Affairs programs and activities will fulfill the following criteria: be scientifically and clinically sound, meet the needs of the medical and patient communities or other constituencies, and be executed in compliance with applicable laws, regulations and company policies.

Responsibilities

KEY RESPONSIBILITIES

• In collaboration with the Executive Medical Director of Medical/Scientific Affairs, Oversee the Medical Information vendor in data analysis, tracking FAQ trends and assuring all materials are current and in compliance with company and regulatory policies.
  • Manage and update SOPs for Medical Information
  • Manage and update all SRLs
  • Manage training as it pertains to Medical Affairs
• Serve as Medical/Scientific Affairs Lead in product safety related activities that are related to medical information by participating in meetings with the Pharmacovigilance and Quality Assurance departments
• In collaboration with the Executive Medical Director of Medical/Scientific Affairs, support the resolution of medical information escalations and product queries.
• Support the execution of all timelines and coordination with the Executive Medical Director, Medical/Scientific Affairs for all Scientific Communications and Publications
  • Support the internal editorial process between cross functional teams and external communication with the journals and authors
  • Support the publication management process and ensure accurate and timely record keeping within the company's publication tracker
• Coordinate and support the creation of scientific presentations and other materials as directed by the Executive Medical Director of Scientific/Medical Affairs.
• Plan and lead the continued operation of the BOAST scientific platform and WIKI
  • Ensure maintenance of functionality
  • Coordinate crucial updates to the scientific platform
  • Support the generation of new materials and facilitate their availability in the BOAST platform
  • In collaboration with Field Medical Director, audit BOAST platform semi-annually to assure all scientific content is current
  • Manage external Vendor
• Coordinate all deliverables pertaining to the Competitive Intelligence and Medical Insights (CI/MI) project.
  • Support the strategic analysis of monthly and quarterly reports as well as the dissemination of these competitive intelligence and medical insights reports to Medical Affairs HQ personnel.
  • Support Executive Medical Director, Medical/Scientific Affairs in setting strategy and corresponding tactics based on results related to CI/MI reports.
  • Coordinate system updates to streamline automation and ensures there is follow-up on action items from the Field Medical team
  • Support the planning and execution of external scientific communications, in response to the CI/MI strategic analysis of monthly reports
• Function as an internal Subject Matter Expert (SME) on disease state, clinical data, and other considerations impacting patient care.
• Assist the Executive Medical Director, with ad hoc projects and duties as needed.
• Complete all company and job-related training as assigned within the required timelines.

QUALIFICATIONS

Education

• Required: Advanced Degree in Life Sciences: PharmD or PHD.

Professional Experience

• 3-5 years of industry experience in pharmaceutical, medical device or biotech.
• Rare disease experience. Neuroscience preferred.

Knowledge and Skills

• Ability to develop and maintain credible relationships with internal pharma colleagues and external constituents (medical community, patient community, support service contracts).
• Strategic thinker who can clearly anticipate future needs, consequences, and trends and then develop and drive appropriate tactical plans to fill these strategic imperatives.
• Demonstrated knowledge of regulations governing non-promotional activities coupled with highly developed sense of ethics, integrity and commitment to patients and customers.
• Possesses fundamental leadership skills.
• Good oral/written communication skills.
• Excellent planning and organizational skills demonstrated independently as well as within cross-functional teams.
• Drive for Results through Accountability, Development, Agility, and Integrity.
• Must be able to travel 5-10% of the time, or as needed.

Additional Information

The base salary range for this full-time position is $145,000 - $175,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory. If you are 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 use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to [e-mail].