Merck Managing Medical Writer, Informed Consent (Remote) in Columbia, South Carolina
The Medical Writing Department of the GCTO organization prepares a variety of regulated documentation to support the clinical development portfolio. Preparation of informed consent for potential participants in clinical trials is essential to good clinical practice, participant recruitment and retention.
The Managing Medical Writer, Informed Consent (MMWIC) is responsible for the preparation of informed consent documents that disclose information about a clinical trial using health literate language to allow a participant to make an informed decision about participation in conjunction with the investigator or his/her delegate, the maintenance of subject matter expertise in this area, and a variety of activities associated with people management.
Be responsible for the leadership of, and strategic and scientific contributions to, the preparation of Informed Consent documentation in support of the clinical development pipeline.
Lead or contribute to process improvement initiatives.
Be responsible for quality and compliance with internal and external standards.
Oversee the timely and efficient production of English-language, global informed consent templates and study-specific templates using appropriate company document management systems.
Facilitate and collaborate with internal and external stakeholders in support of clinical documentation objectives.
Contribute experience, insight and knowledge of appropriate regulatory and other guidance to the production of appropriate informed consent documentation.
Effectively manage direct reports, including assignment of resources, professional development and performance management.
Build talent and capabilities of informed consent medical writing team members through coaching, mentoring and development opportunities.
Lead the MW handling of special projects in informed consent documentation (eg, risk language updates).
Oversee multiple clinical areas or disease areas regarding their informed consent documentation requirements.
Appropriately escalate challenges/issues to senior management as needed.
Forecast resource needs; manage allocated budget.
Education Minimum Requirements
Degree in the Life Sciences
Bachelor’s degree with 12+ years; or MS with 10+ years; or PhD with 6+ years relevant career experience
Required Experience and Skills
Degree in the Life Sciences
Bachelor’s degree with 12+ years; or Masters-level with 10+ years; or PhD with 6+ years relevant career experience
6+ years of relevant medical writing experience
Demonstrated experience of translating scientific material for a lay audience, and strong knowledge of health literacy principles. 2+ years of people management experience including managing direct reports as well as managing vendor-supplied resources
Knowledge of regulatory guidance governing informed consent
Evidence of leadership and activity in a patient-facing or research-participant-facing domain
Excellent oral (including presentation) and written communication, project management and change management skills.
Awareness of pharmaceutical industry needs beyond clinical development.
Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with, Veeva, SharePoint and concepts of structured content management
Preferred Experience and Skills
- Training in medical ethics
We are a research-driven bio-pharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
Invent. Impact. Inspire.
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Flexible Work Arrangements:
1st - Day
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Number of Openings:
Requisition ID: R116856