Sr Medical Writer - Late Phase - Inflammation

Job Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Led the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• Covers quality and editorial reviews.
• Ensures source documentation is managed appropriately.
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Provides feedback to further define statistical output required and document needs.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues, escalating as appropriate.
• Provides technical support, training, and consultation to department and other company staff.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
• Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
• Completes required administrative tasks within the specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

Minimum of a Bachelor's degree in a relevant field such as Biomedical Sciences, Life Sciences, or a related field. A Master's degree is preferred.

At least 5 years of experience in medical writing, preferably in a pharmaceutical or biotech setting.

Experience with ICH E3 guidelines and familiarity with regulatory standards.

Strong knowledge of medical terminology, pharmacology, and clinical research principles.

Excellent written and verbal communication skills, with the ability to communicate complex medical information to non-medical audiences.

Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.

Ability to manage multiple projects simultaneously and meet deadlines.

Strong organizational and project management skills.

Ability to work independently and as part of a team.

Ability to interact effectively with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs.

Ability to conduct systematic literature searches and reviews.

Ability to analyze and interpret statistical outputs.

Ability to prepare literature for new products and revise existing medical communication.

Ability to prepare briefing books and response documents to health authority questions.