Senior Medical Writer – Medical Affairs
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Job Description
Senior Medical Writer developing medical content for pharmaceutical and medical device clients at Red Nucleus. Collaborating with teams to produce high-quality medical communications while ensuring regulatory compliance and scientific integrity.
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; These meetings 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:
- Minimum of 4 years of relevant medical communications/medical writing experience
- 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 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
Benefits:
- Competitive pay, incentives, retirement, and income security programs
- Comprehensive benefits and wellness programs focused on healthy lifestyles
- Generous paid time off, employee assistance programs, and flexible work arrangements
- Performance-driven environment including professional development and transfer opportunities
- People-first culture fostering self expression, diversity, and a growth mindset
- Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones, and anything else that is meaningful to our employees
- Support of the community organizations you are passionate about
- Ongoing programs and events designed to bring our global team together
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