Merck Managing Medical Writer (Remote) in Baton Rouge, Louisiana
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.
The Managing Medical Writer is responsible for development and management of medical writing deliverables that support the clinical regulatory writing portfolio. The managing Medical Writer is an integral part of a clinical and/or study team capable of working independently to achieve goals.
In this role the Managing Medical Writer is responsible for:
Leadership of, and strategic and scientific contributions to the preparation of regulatory documentation in support of the clinical development pipeline.
Quality and compliance with internal and external standards.
Timely and efficient production of English-language clinical regulatory documents using an electronic document management system.
Must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.
May have overarching responsibilities for oversight of multiple clinical programs or disease areas.
Directs teams in development of documentation roadmap (e.g., strategic program level overviews as well as details for specific deliverables, timelines, resources, expected deliverables, review cycles, issue escalation/mitigations, presentations to Sr. Management as needed).
Leads dossier preparation and writes key documents and/or oversees the writing of others.
Builds talent and capabilities of medical writing team members through proactive coaching, mentoring and development opportunities.
Facilitates and collaborates with internal and external stakeholders in support of clinical documentation objectives.
May include management of direct reports including assignment of resources, professional development and performance management.
Leads or contributes to process improvement initiatives.
Qualifications, Skills, & Experience:
Degree in the Life Sciences.
Bachelor’s degree with 12+ years; or MS with 10+ years; or PhD with 6+ years relevant career experience.
At least 6 years of medical writing experience preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
At least 2 years of people management experience with direct reports, preferred.
Provide leadership of and management for complex documentation projects and project teams of medical writers.
Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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.
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Requisition ID: R130052