Requisition ID: CLI008379
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Responsible for leadership 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. 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 particular deliverables, timelines, resources, expected deliverables, review cycles, issue escalation/mitigations, presentations to Sr. Management as needed), leads dossier preparation (CTD submissions), 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.
Education Minimum Requirement: Bachelor's Degree or higher in the Life Sciences
Required Experience and Skills:
- Minimum of 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.
- Minimum of 2 years of people management experience with direct reports.
- 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.
- Excellent oral (including presentation) and written communication, and project management skills.
P referred Experience and Skills:
- Advanced degree in Life Sciences
- Experience in oncology medical writing
- Familiarity with c oncepts of structured content management.
*Domestic relocation available or remote based work
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Visa sponsorship is not available for this position.
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Job: Clinical Research - Clin Ops
Other Locations: Rahway, NJ, US; Upper Gwynedd, PA, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Hazardous Materials: no
Company Trade Name: Merck
Nearest Major Market: Boston