Description
**Group Purpose**
To prepare scientific and regulatory submission documents that comply with global and local regulatory standards
**Job Summary**
To author and gain approval of scientific and regulatory submission documents that comply with global and local 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 regulatory submission documents, as assigned, including Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and other regulatory documents according to the local needs;
– Conduct the formal review and approval of authored documents, following applicable standard operating procedures;
– With considerable supervision, manage regulatory writing activities for local product submissions, including new and supplemental drug applications/biologics license applications;
– Serve as functional area lead on local product teams – May provide functional area input for Local Regulatory Plan and team goals
– Work with CRO and freelance writers
– Participate in departmental and cross-departmental initiatives as appropriate
– May participate in training and mentoring of junior regulatory 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:
– Ability to analyze scientific data and interpret its significance in practical applications, with limited oversight;
– Excellent written/oral communication skills and attention to detail in local native language;
– -Upper-intermediate level business English (capable of communicating appropriately in most situations, equivalent to TOEIC score of 730+;
– Highly skilled 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
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Preferred Knowledge and Skills:
– Understanding and application of principles, concepts, theories and standards of scientific/technical field.
– Advanced knowledge of document management systems.
– Substantial knowledge and understanding of International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidances and requirements relevant to regulatory submissions.
**Education & Experience (Basic)**
Doctorate degree
OR
Master’s degree and 3 years of directly related experience
OR
Bachelor’s degree and 5 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience
OR
High school diploma / GED and 12 years of directly related experience
**Education & Experience (Preferred)**
Experience with regulatory documents in Regulatory Affairs, Research, Development, or related area
5+ years experience in medical writing in the Biotech/Pharmaceutical industry
