Medical Writer (Medical Affairs)

About This Role

This role involves developing accurate and scientifically sound medical content for pharmaceutical and medical device clients. The Medical Writer acts as the lead for assigned clients, brands, or therapeutic areas, ensuring all materials meet regulatory and client standards across various initiatives.

Responsibilities

• Perform medical literature research and data analysis to support project pitch development, new content development, and regulatory review/approval
• Develop medical and scientific copy, highlighting/tagging references as required for all sales and client-driven initiatives
• Support project pitch development and delivery by providing medical and scientific expertise to client engagement teams
• Provide medical and scientific support during client meetings, workshops, and advisory board meetings, which may occur virtually or in person
• Edit copy to correct errors of spelling, grammar, and punctuation, ensure stylistic consistency, enhance readability, and ensure copy meets branding and referencing requirements
• Work within copy deck formats that appropriately record changes, style decisions, source materials, and referencing requirements
• Prepare and submit content for medical legal regulatory review in client submission/referencing systems
• Participate in client calls/correspondence relating to content approval; record and clarify all content change requests and ensure relevant information is shared with other production team members
• Collaborate with Design to ensure visuals are scientifically accurate and align with client preference/style guide and regulatory guidelines
• Collaborate with Animation to write and review scripts, review storyboards, and video output
• Collaborate with the User Experience team to establish organization and flow of content; review IA/wires/functional spec documents for scientific accuracy
• Collaborate with editorial team members to ensure alignment with client branding and ensure accuracy of spelling, punctuation, and grammar
• Conduct end-to-end validation of the content of projects, reporting and resolving issues with relevant team members including the project manager and/or account management personnel
• Assist with the creation of budget estimates for new/revised projects
• Participate in the development, implementation, and control of editorial standards and workflow optimization
• Educate team members on scientific constructs, as needed, to ensure understanding and alignment on content development
• Ensure alignment with other team members and clients on deliverables
• Oversee communication with team members in Pune who support with regulatory submissions and scientific accuracy
• Navigate daily tasks and support Project Managers to address resourcing challenges

Requirements

• Advanced degree in life sciences (MSc, PhD, PharmD, or MD)
• Minimum 2 years of relevant medical information, communications, or marketing writing experience (agency, pharmaceutical, or independent)
• Understanding of clinical research, the drug development process, and applicable regulatory guidelines
• Exemplary written, verbal, analytical, and editing skills
• Experience with presenting and interacting with medical and scientific experts, utilizing problem-solving skills
• Detail-oriented and highly organized individual
• Naturally inquisitive and attentive individual, who is able to ask and answer enquiring questions
• Enjoys the challenge of interweaving multiple tasks within a deadline-oriented, fast-paced environment
• Team player with good interpersonal skills
• Previous experience working with health care clients in an agency setting
• Prior experience in digital media, web applications, or new technology
• Prolonged sitting at a desk or workstation while using a computer, attending virtual meetings, and performing job duties
• Repetitive hand and finger motions for typing, data entry, and use of standard office equipment (keyboard, mouse, phone)
• Ability to lift and carry light items (generally up to 10–15 pounds), such as a laptop, files, or small office supplies
• Ability to maintain a safe and ergonomically appropriate home workspace in compliance with company guidelines

Important Details

• Locations: US, Canada, or UK
• Schedule: Monday through Friday, 8:30am to 5:30pm EST
• Occasional travel may be required for team meetings or company events

About the Company

Red Nucleus is a global provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. The company has nearly 1000 full-time employees and has been internationally recognized as a “Great Place to Work”.