Senior Medical Writer

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided. The SMW tracks their own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion.

As a Senior Medical Writer, a typical day may include the following:

• Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided

• Represents MW at meetings

• Drives document development meetings

• Articulates document strategy and timelines

• Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss

• Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly

• Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development

• Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience

• Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area

• Remains compliant with internal training

This role may be for you if:

• Strong organizational, interpersonal and communication skills

• Ability to manage multiple projects

• Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict

• May mentor junior staff

To be considered for this role, you must have a Bachelor's degree (advanced degree preferred) Additionally, a minimum of 3 years of relevant MW experience including working knowledge of biostatistics. We are seeking strong knowledge of the clinical research process and regulations/guidelines; hands on experience with clinical document reading, writing, and editing experience. Proficient in MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems. Familiarity with ICH GCP guidelines.