Job description

Simulations Plus is a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry. Our biosimulation solutions integrate artificial intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling.

We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide.

Leadership truly cares about maintaining a positive culture and employee well-being. We offer fully remote work, flexible schedules, and generous vacation policy along with affordable health coverage, stock options, annual bonuses, and more!

The Associate Medical Director will write and develop medical/scientific materials for education, insights gathering, and training; includes development of materials such as presentations, enduring materials, and digital content. The role is responsible for the accuracy of the content development from conception to completion.

Business Unit: Medical Communications (MC)

Internal Grade: 14

Direct Reports: No

Status: Exempt

Location: Remote

Job Responsibilities:

Serve as the medical/scientific content strategy and execution lead for client projects to develop promotional and non-promotional materials such as slide decks, case studies, meeting summaries, white papers, training modules, discussion guides, surveys, etc.
Plan and execute medical strategy and engagement for clients
Provide strategic insights and clinically relevant perspective to clients
Develop deep understanding of disease states, market dynamics, and current medical and/or regulatory issues related to various products
Serve as the subject matter and therapeutic expert lead: conducting background research utilizing the medical/scientific literature, treatment guidelines, market research results, and other sources
Serve as an internal disease-area scientific and research expert to support cross-functional strategies and other scientific communication deliverables
Gather, organize, interpret, and present information in a manner appropriate for the target audience
Establish strong relationships and collaborate with physician opinion leaders and client representatives including marketing directors, legal, regulatory, and medical teams
Attend client meetings and medical conferences to provide on-site medical/scientific content support
Review and provide oversight in content developed by fellow medical writers to ensure quality control on content and context
Collaborate with internal teams to plan, execute, and deliver on client projects
Participate in discussions regarding the creation of departmental SOPs addressing processes and procedures necessary to achieve organizational objectives
Ownership of the scientific accuracy and integrity of materials developed
Produce high quality output while managing competing deadlines, shifting priorities, and working within the projected budget
Other duties as assigned

Qualifications:

3+ years medical director, writer or related experience
Experience with materials requiring medical/regulatory/legal (MRL) reviews preferred
General knowledge of medical sciences, healthcare delivery, and the pharmaceutical/biotechnology industry
Oncology/Hematology/ Immunology experience strongly preferred
Understand regulations governing the biotechnology and pharmaceutical industries
Excellent verbal and written communication skills
Strong presentation skills
Maintain an objective and professional attitude
Excellent interpersonal skills and effectively collaborate with a multifunctional team
Self-directed and work well under pressure
Excellent organizational and time management skills
Strong attention to detail
Ability to work in a fast-paced, collaborative environment
Accept constructive criticism well
Strong computer and software skills
Some travel up to 25% required for client meetings and conferences

Education: