Senior Medical Writer – Late Phase Inflammation

This is a fully remote position, open to applicants in Spain.

📋 Description

• Oversees the precise and thorough completion of medical writing deliverables, ensuring that scientific information is communicated clearly and accurately.

• Directs medical writing activities related to individual studies, facilitating coordination of these activities across departments with minimal oversight.

• Takes the lead in addressing feedback from clients.

• Produces a wide range of documents, which may include clinical study protocols and their amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; as well as abstracts, posters, and presentations for scientific meetings.

• Follows established regulatory standards, including but not limited to ICH E3 guidelines, as well as company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guidelines, ensuring projects are completed on time and within budget.

• Manages quality and editorial reviews.

• Ensures appropriate management of source documentation.

• Leads document reviews within the team and assesses documents as necessary.

• Functions as a peer reviewer for the internal team to ensure scientific content, clarity, consistency, and proper formatting of documents.

• Reviews statistical analysis plans and specifications for tables, figures, and listings for appropriate content, grammar, format, and consistency.

• Provides constructive feedback to further clarify statistical outputs and document requirements.

• Engages and cultivates positive relationships with clients, department heads, and colleagues in data management, biostatistics, regulatory affairs, and medical affairs as needed to deliver writing outputs.

• Conducts online clinical literature searches and adheres to copyright requirements.

• Identifies and suggests solutions to address issues, escalating them as necessary.

• Offers technical support, training, and consultation to the department and other company personnel.

• May assist in the development of internal materials and presentations or modifications to internal processes, standard practices, and capabilities.

• Mentors and guides less experienced medical writers on complex projects as needed.

• Develops in-depth knowledge of key industry topics and relevant regulatory requirements and guidelines that impact medical writing.

• Maintains awareness of project budget constraints, ensuring work is completed within budgeted hours and communicating updates and changes to medical writing leadership.

• Completes necessary administrative tasks within specified timeframes.

• Performs additional work-related duties as assigned.

⛳️ Requirements

• Oversees the precise and thorough completion of medical writing deliverables, ensuring that scientific information is communicated clearly and accurately.

• Directs medical writing activities related to individual studies, facilitating coordination of these activities across departments with minimal oversight.

• Takes the lead in addressing feedback from clients.

• Produces a wide range of documents, which may include clinical study protocols and their amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; as well as abstracts, posters, and presentations for scientific meetings.

• Follows established regulatory standards, including but not limited to ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guidelines.

• Manages quality and editorial reviews.

• Ensures appropriate management of source documentation.

• Leads document reviews within the team and assesses documents as necessary.

• Functions as a peer reviewer for the internal team to ensure scientific content, clarity, consistency, and proper formatting of documents.

• Reviews statistical analysis plans and specifications for tables, figures, and listings for appropriate content, grammar, format, and consistency.

• Provides constructive feedback to further clarify statistical outputs and document requirements.

• Engages and cultivates positive relationships with clients, department heads, and colleagues in data management, biostatistics, regulatory affairs, and medical affairs as needed to deliver writing outputs.

• Conducts online clinical literature searches and adheres to copyright requirements.

• Identifies and suggests solutions to address issues, escalating them as necessary.

• Offers technical support, training, and consultation to the department and other company personnel.

• May assist in the development of internal materials and presentations or modifications to internal processes, standard practices, and capabilities.

• Mentors and guides less experienced medical writers on complex projects as needed.

• Develops in-depth knowledge of key industry topics and relevant regulatory requirements and guidelines that impact medical writing.

• Maintains awareness of project budget constraints, ensuring work is completed within budgeted hours and communicating updates and changes to medical writing leadership.

🏝️ Benefits

• We are dedicated to fostering the growth of our employees through career development and advancement; supportive and engaged line management; training in technical and therapeutic areas; peer recognition; and a total rewards program.

• We are committed to creating an inclusive culture where you can genuinely be yourself.

• Driven to Deliver – a reflection of our colleagues' passion to show up each day and create solutions that can significantly impact someone's life.