Merck Senior Medical Writer, Oncology in North Wales, Pennsylvania
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 as a Medical Writer!
Our Medical Writing Department strives to be the premier regulatory documentation organization in the bio-pharmaceutical industry. Our Medical Writers are integral to helping bring medical breakthroughs to the world. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, and innovative medicine. We rely on expert skills and inventiveness that contribute to solutions to the most pressing health challenges.
The Senior Medical Writer is responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio and works with some guidance and oversight to achieve goals. In this role the Senior Medical Writer:
Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation
Applies knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects
Represents medical writing in cross-functional teams
Demonstrates competence in writing, editing, and reviewing clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines
Interprets data and applies knowledge of regulatory/compliance/scientific requirements to document preparation
Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings
Solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members
May participate in orientation and coaching of junior team members or contractor writers
Participates in or leads initiatives to improve medical writing processes and standards
Education Minimum Requirement: Bachelor's Degree or higher in the Life Sciences
Required Experience and Skills:
Bachelor’s degree with 5+ years; MS with 4+ years; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 3+ years of relevant career experience
Ability to prepare, with minimal supervision, a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/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
Demonstrated participation in medical writing, document, and project teams
Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint). Familiarity with concepts of structured content management preferred
Demonstrated excellent presentation, writing, and project management skills
Preferred Experience and Skills:
Experience in oncology regulatory writing
Advanced degree in Life Science
Familiarity with concepts of structured content management
*Remote opportunity available; if not located near a headquarters location (NJ, PA, NC, Boston)
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. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R84520
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