Kelly Services is currently seeking a REMOTE Principal Medical Writer to work a contract assignment 6 month duration for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100™ companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.
Primary Responsibilities includes:
• Within a designated therapeutic area the Principal Medical Writer Program Lead formulates the writing strategy for key clinical documents and regulatory submissions. Guides medical writing (MW) document preparation, including coordination and oversight of assignments to MW vendor (s). Assumes primary medical writing responsibility for preparation of key regulatory response documents and strategic documents supporting major regulatory submissions. Formulates writing approach, develops timelines, and assesses resource requirements. Participates on relevant project teams and task forces, and 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, requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents. Leverages external resources to achieve quality, timely and cost-effective compound level submission deliverables.
• Leads a single team which guides medical writing activities within a designated therapeutic area for key response documents and regulatory submissions.
• Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
• Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
• Coordinates and provides oversight for the activities of medical writing vendor(s), and ensures resolution of issues.
• Within designated therapeutic or compound function, 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 requirements and processes across development programs.
• As required, serves as lead writer for strategic regulatory documents and key components of regulatory submissions.
• Provides leadership on functional teams that address requirements or issues related to document preparation and production.
• The Principal Medical Writer Program Lead is seen as an expert in medical writing and performs work independently with minimal supervision.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• Bachelor's degree in science, health profession, or journalism required.
• At least 5 years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required
• Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from 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).
• Ability to understand guidelines and requirements related to the preparation and production of regulatory documents and submissions.
• 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.
For immediate consideration, please send your resume in a WORD document to firstname.lastname@example.org
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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