Managing Medical Writer, Oncology at Merck
Managing Medical Writer, Oncology (Remote)
- Full Time
Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe.
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.
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.
- 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.
- 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.
- Guides 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.
- Oversees or contributes to process improvement initiatives
- Degree in the Life Sciences
Required Experience and Skills:
- Bachelor’s degree with 12+ years; or MS with 10+ years; or PhD with at least 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.
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