Senior Medical Writer (Medical Affairs)

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.
• Edit copy to correct errors of spelling, grammar and punctuation, ensure stylistic consistency, enhance readability, and ensure copy meets branding 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.
• Absorb and validate end-to-end content of projects, reporting and resolving issues with relevant team members including the project manager and/or account management personnel.
• Aid in the creation of budget estimates for new/revised projects.
• Participate in the development, implementation and control of editorial standards and workflow optimization.
• Educationally 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.

Qualifications

• 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.
• Naturally 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.
• Previous experience in digital media, web applications or new technology.