Merck Managing Medical Writer, Oncology in Boston, Massachusetts
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
IMPACT OUR TEAM!
Our Medical Writing department strives to be the premier regulatory documentation organization in the biopharmaceutical industry. Our Medical Writers are integral to helping bring medical breakthroughs to the world. We rely on expert skills and inventiveness to realize this life-saving goal.
Accountable for guidance of, and strategic and scientific contributions to, the preparation of regulatory documentation in support of the clinical development pipeline. As an integral part of a clinical and/or study team, the Managing Medical Writer ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical regulatory documents using an electronic document management system. Contribute scientific knowledge, diagnostic skills, experience, and insight to the interpretation of data, the preparation of reports, and the production of registration dossiers. May have overarching tasks for oversight of multiple clinical programs or disease areas. Guides teams in development of documentation roadmap (e.g., strategic program level overviews as well as details for particular deliverables, timelines, resources, expected deliverables, review cycles, issue escalation/mitigations, presentations to Sr. Management as needed), guides 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 partners 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. Guides or contributes to process improvement initiatives.
Education Minimum Requirement: Degree in the Life Sciences
Required Experience and Skills:
Bachelor's degree with 12+ years; or MS with 10+ years; or PhD with 6+ years relevant career experience.
At least 6+ years of experience as a medical writer 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.
Provide guidance 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.
- Experience in oncology medical writing
*Preference to be located near NJ, PA, Boston or NC sites, but remote based is an option.
We are a research-driven biopharmaceutical 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 .
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Flexible Work Arrangements:
Remote Work, Telecommuting
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R78631
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