Associate Medical Writer

**Job Description**:
The Medical Writing Department of the Global Clinical Trial Operations organization prepares a variety of regulated documentation in support of the clinical development portfolio.

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.

**The Associate Narrative Medical Writer (MW)** is responsible for the development of medical writing deliverables for a limited set of documents within a single therapeutic area under the supervision of management and Principal Medical Writer Safety Lead. The MW supports the clinical development pipeline through scientific contribution of clinical documents related to safety. The MW delivers quality English language documents in compliance with internal conventions and industry standards in a timely and efficient manner following the department and company processes and tools.

The Associate Medical Writer works with guidance and oversight to develop
- Prepares selected components of regulatory clinical documentation
- Develops knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects
- Participates, with supervision, on document-specific teams
- Develops competence in writing, editing, and reviewing clinical study reports, patient narratives, investigator brochures, and other clinical regulatory documents per company and other guidelines
- Acquires a thorough understanding of medical writing responsibilities, including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings
- Identifies challenges 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 initiatives to improve medical writing processes and standards

Qualifications, Skills & Experience
- Degree in a life science, preferably related to pharmacy or medicine
- Bachelor’s degree with 2+ years; MS with 1+ year; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 1 year of relevant career experience
- Demonstrated ability to write scientific documents (e.g., lab reports, publications, dissertations, theses, abstracts)
- Experience working on teams
- Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat)
- Demonstrated presentation, writing, and project management skill
- Proficiency in English

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., Rahway, 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**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace

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**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R236630