Premier Research is hiringDirector, Medical Writing

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Job Description

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
  • Manages staff writers, contract writers, and vendors and is accountable for the quality of the work produced
  • Ensure conversion of scientific data into clear, sound, well-structured scientific, clinical and regulatory submission documents to global health authorities
  • Develops organizational policies and authorizes their implementation and follow relevant styles and references in support of the company’s product development plans and objectives
  • Independently write, manage, review, format and obtain approval of clinical documents including, clinical study reports, synopses and protocols, documents for regulatory submissions ( e.g. meeting packages, investigational new drug (INDs) applications, and sections of marketing applications (NDA/BLA/MAA/CTD), Investigator Brochures, or other clinical and regulatory documents)
  • Interpret clinical and non-clinical data in the preparation of various documents
  • Manage all medical writing projects and report their status to senior management
  • Coordinate with other internal Regulatory Affairs and Regulatory Operations team members to develop deliverables for clients
  • Takes the initiative to liaise with other departments to share information about medical writing services and capabilities
  • Review all relevant documents and interact with internal Regulatory team members and external clients to develop a thorough understanding of project timelines
  • 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
  • Attend proposal meetings with prospective clients and produce writing costs, timelines, and project assumptions
  • Provide information to implement changes orders for all department-related activities as needed
  • 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
  • Write and/or review departmental SOPs
  • Oversee the process as well as devise, review, revise and update templates, trackers and any departmental forms Manage, mentor, and recruit medical writing staff
  • Provide training of medical writing staff and ensure compliance to company Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH) guidelines, and staff training requirements

What We Are Searching For

  • Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD/PharmD in a scientific or medical discipline preferred
  • 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)
  • Depth of industry and drug development knowledge
  • 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
  • Superior working knowledge of software programs in Windows environment with advanced proficiency in word processing, flow diagrams, and spreadsheets
  • Ability to learn fast, grasp the 'essence' of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports
  • Excellent organizational, writing, communication and time management skills needed to manage a team as well as multiple ongoing projects simultaneously to meet timelines
  • Exceptional attention to detail
  • Advanced analytical skills and strong knowledge of medical terminology
  • Cross therapeutic experience across therapeutic areas and phases

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.

#LI-JD1 #Remote

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