Career Category

Safety

Job Description

Group Purpose

To prepare safety documents (RMP/REMS/aRMMs), scientific and regulatory submission documents that comply with global regulatory standards.

Job Summary

To author and gain approval of safety document RMP/REMS/aRMMs), and if required, scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities.

Key Activities

With limited supervision:

-Author safety documents (RMP/REMS/aRMMs) and ACO.

• Conduct the formal review and approval of authored documents, following applicable standard operating procedures;

• With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications;- Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team Label Working Group)- May provide functional area input for Global Regulatory Plan and team goals.

• May participate in training and mentoring of junior medical writers

• May participate in departmental and cross-departmental initiatives, as appropriate;

• Generate document timelines, with team input;

• Keep abreast of relevant professional information and technology

Knowledge and Skills:

Required Knowledge and Skills:

• Extensive writing experience of RMP/REMS

-Ability to analyze scientific data and interpret its significance in practical applications, with limited oversight;

• Excellent written/oral communication skills and attention to detail;

• Proficiency with word processing and other Microsoft Office Programs

• Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds;

• Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;

• Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions;

• Proficient time and project management skills.

• Self-starter with a drive and perseverance to achieve results

Preferred Knowledge and Skills:

• Understanding and application of principles, concepts, theories and standards of scientific/technical field.

• In-depth knowledge of document management systems.

• Substantial knowledge and understanding of International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidances and requirements, GVP guidelines.

Education & Experience (Basic)

Doctorate degree
OR
Master’s degree and 8+ years of directly related experience
OR
Bachelor’s degree and 10+ years of directly related experience.

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