Assoc Director / Sr. Writer, Regulatory Writing
Insmed Incorporated

Job Info

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Company Description

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Recognitions

Named Science's 2021 Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's 2021 Top Employers Survey.

A Certified Great Place to Work

We believe we have built something truly special at Insmed, and our employees agree. Each day, we show up for each other and for the patients we serve. That's why we were recently certified as a Great Place to Work in the U.S.

Overview

Working across therapeutic programs to provide expert support as needed, the Regulatory Writer formulates the writing strategy for, and authors key regulatory documents for regulatory submissions; guides regulatory writing document preparation, including coordination, review, and substantive editing of documents.

This is a non-supervisory position.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Provides writing expert support to Regulatory Leads as needed in preparing regulatory documentation and regulatory submissions.
• Formulates the writing strategy for key regulatory documents and regulatory submissions.
• Authors regulatory documents and guides regulatory writing document preparation, including coordination with SMEs, provides review, editing, and QC of documents.
• As necessary, may assume primary responsibility for the preparation of key regulatory documents and documents supporting major regulatory submissions, meeting briefing documents, as well as responses to regulatory agencies/ health authorities.
• Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions working with the designated functional area.
• Participates in relevant project teams as required.
• Provides functional and cross-functional guidance on a wide range of issues related to document preparation, including the US and international regulatory guidelines and requirements for content and format, Insmed's requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
• Collaborate with internal and external resources to achieve high-quality, timely submission deliverables.

Qualifications

• For the Sr. Writer, Bachelors' or graduate degree in a scientific discipline or equivalent with at least 7 years' experience or graduate degree with at least 5 years of experience is required.
• For Assoc Dir, Bachelors' or graduate degree in a scientific discipline or equivalent with at least 8 years' experience or graduate degree with at least 7 years of experience is required.
• Experience with submission writing and review is essential
• Experience as the lead writer for key documents included in the major US and/or international regulatory submissions
• Experience managing writing activities for the major US or international regulatory submission
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from non-clinical to clinical protocol design through regulatory submission and support for marketed products.
• Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
• Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
• Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
• Knowledge of team dynamics and ability to function as a team leader.
• Excellent organizational, planning, and follow-up skills. Must be able to meet tight deadlines and be efficient, detail-oriented, flexible, and a self-starter.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Travel Requirements

Minimal travel (approximately 10%) may be required

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep all submissions on file for six months.

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