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 Medical Writer is responsible for development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals.In this role the Medical Writer:
- Is recognized as a scientific contributor in preparation of regulatory clinical documentation
- Applies developing knowledge of regulatory medical writing and therapeutic area/ investigational product to support pipeline projects
- Is a contributing member of medical writing in cross-functional teams
- Demonstrates growing competence in writing, editing, and reviewing clinical study reports, patient narratives, investigator brochures, and other clinical regulatory documents per company and other guidelines
- Learns to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation
- Acquires and applies 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 and proposes solutions to 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
- Participates 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 4+ years; MS with 2+ years; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with 1+ year of relevant career experience
- Ability to prepare, with supervision, a subset of clinical regulatory documents (e.g., CSR shell or appendices, IB update, patient narratives) according to company guidelines and international governmental regulations, and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
- Experience working on cross-functional teams
- Technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., Google Docs, SharePoint)
- Demonstrated presentation, writing, and project management skills
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 worlds 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.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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Pay Transparency Nondiscrimination
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.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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