Medical Writer Consultant

As a Medical Writer, you will be empowered to formulate and execute the writing strategy for key clinical and regulatory documents and regulatory submissions.

Responsibilities:

Performs medical writing activities for key clinical and regulatory documents and regulatory submissions.
Provides functional and cross-functional guidance on a wide range of issues related to document preparation, including US and international regulatory guidance and requirements for content and format, Company requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
Assumes primary responsibility for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities.
Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area.
Collaborates with internal and external resources to achieve high quality, timely program level submission deliverables.
Provides review and substantive editing of documents.
Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications.
Manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Company requirements and processes across development programs.

Requirements / Qualifications:

A minimum of a Bachelor’s degree in a relevant scientific/clinical/regulatory field is required.
At least 10 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required.
Therapeutic Area: Infectious Disease preferred.
Experience as lead writer for key components of major US and/or international regulatory submissions in eCTD format required.
Experience managing writing activities for a US or international regulatory application (project or people management) preferred.
Experience working with eDMS.
Highly organized with strong attention to detail, clarity, quality, accuracy, and conciseness.
Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace.
Must be an experienced, influential, and credible professional who is able to establish and maintain effective and successful working relationships both internally with all Staff, and with external technical and medical experts, in a collaborative and cohesive manner.
Able to work collaboratively in a team-oriented environment, taking on responsibility and accountability for assigned programs.
Able to balance strategic approach with the needs of an organization requiring hands-on work, while addressing competing priorities that may require, at times, a sense of urgency.