Senior Medical Writer

Resolvit.com - Remote

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as a Senior Medical Writer and be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the Senior Medical Writer, you will provide high-quality medical and scientific writing, from planning and coordination of literature search through delivery of final drafts to internal and external clients. You will provide technical consultation and substantive advice on strategy, regulations, and industry best practices. You will also demonstrate subject matter and therapeutic area expertise. Additionally, you will:

  • Effectively manage medical writing projects to deliver quality products in agreed timelines
  • Collaborate with internal and external clients to support and enable effective and efficient communication that results in operational excellence
  • Independently research, write, and edit clinical study reports, study protocols, and standard response documents
  • Produce complex clinical or scientific documents such as IBs and sections of INDs, NDAs, CTDs, and dossiers
  • Provide senior review of documents and training/mentoring for other writers
  • Manage all aspects of planning, organizing, and executing projects without supervision, including developing project timelines, standards, budgets, forecasts, and contract modifications
  • Liaise with other functional units as necessary (project management, clinical, QA, data management, biostatistics, regulatory)
  • Identify and escalate out-of-scope project activities in a timely manner and propose solutions
  • Manage several long-term projects concurrently
  • Represent medical writing in project launch meetings, review meetings, client audits, bid defenses, and capabilities presentations
  • Establish and develop client relationships; independently initiate and lead interactions with clients
  • Assist with business development and development of budgets and proposal

What You’ll Need to be Successful:

  • At least 5 years of relevant experience; pharmaceutical/CRO industry experience preferred
  • Bachelor's degree in a scientific discipline; advanced degree preferred
  • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading
  • Strong project management skills
  • Excellent interpersonal skills including problem solving
  • Strong negotiation skills
  • Excellent oral and written communication skills with strong presentation skills
  • Significant knowledge of global, regional, national, and other document development guidelines
  • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, or communications
  • Great judgment and decision-making skills
  • Excellent computer skills and skilled with client templates
  • Good knowledge of document management systems and other relevant applications (Excel, Outlook)

Great Additional Skills:

  • Qualifications in medical writing (AMWA, EMWA, RAC)

Benefits:

At Resolvit, you’ll be given the support you need to grow in your consulting career. In addition to opportunities for advancement, we offer:

  • Medical, dental, and vision insurance
  • Life insurance coverage
  • Long-term and short-term disability coverage
  • 401(k) retirement plan with matching
  • Professional support from our Client & Employee Optimization Specialist

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.



Posted On: Friday, March 26, 2021



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  • It is the policy of Resolvit, LLC to provide and administer employment, training, compensation, promotion, benefits and employment practices without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, medical condition, veteran status, marital status, or political affiliation.