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Join Premier Consulting, a division of Premier Research, and be a part of a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, clinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.
We’re seeking a Senior Director, Medical Writing that is passionate about driving innovation from the earliest stages of development. As a member of the Premier Consulting team, you’ll build cross-functional partnerships that enable your growth and success. Help us create tangible solutions for patients in need.
What you’ll be doing:
Oversees the day-to-day activities of the entire Medical Writing Department
Develops organizational policies and authorizes their implementation and follow relevant styles and references in support of the company’s product development plans and objectives
Takes the initiative to liaise with other departments to share information about medical writing services and capabilities
Assist in business development-related activities, such as review of request for proposals (RFPs) from various clients, preparation of bid proposals, and review of consulting agreements
Address any sponsor concerns regarding medical writing deliverables and foster client relationships
Provide direction to senior managers in various areas, groups, and/or operations. Recognized as an influential leader. Interpret and train others regarding current regulatory guidelines pertaining to regulatory documents
What we are searching for:
BS/BA or MS degree and 12-14 years of direct medical/technical regulatory writing experience, or PhD and 6+ years’ experience in medical/technical regulatory writing
6+ years leading medical writing teams
5-7 years personnel management experience
International regulatory experience (EMA, TGA, PMDA)
Extensive understanding of study design, GCP, reporting and regulatory requirements (FDA/EMA/Health Canada/TGA/PMDA)
Extensive knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
Why Choose Premier Consulting, a division of Premier Research?
Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.
We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.
