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Medical Writer

Full-Time
at
Company Location:
Kenilworth
,
US
Job Location:
Remote (US)
Kenilworth
,
US
US
Level:
Senior
Pay:
$
0.00
(
)
Category:
Medical
Posted on:
March 29, 2022
Might be expired
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Job Description

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.

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.

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.

Minimum Required Education

  • Degree in a life science, preferably related to pharmacy or medicine.
  • 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.

Required Experience and Skills

  • 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.

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.

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Eligible for ERP

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

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 usand 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.

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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