Managing Medical Writer-CLI004611
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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Managing Medical Writer (MMW) is a key member of the Medical Writing team who brings expertise and leadership qualities to the writing group. With both a people and project-facing orientation, the MMW is 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 MMW 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, 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.
- Bachelor's Degree in the Life Sciences with 12 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- MS Degree in the Life Sciences with 10 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- PhD in the Life Sciences with 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.
- A minimum of 2 years experience managing people, projects and/or the work of others.
- 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.
- Demonstrated experience in process improvement.
- Active involvement in professional organizations.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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Job: Clinical Research - Clin Ops
Job Title:Principal Scientist, Clinical Operations
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd, NA-US-MA-Boston
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 4
Company Trade Name:Merck
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