Job Description

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.

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 Medical Writer is accountable 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 tasks, 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

Education Requirements

Degree in a life science
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

Qualifications

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
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., 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.

INVENT.

IMPACT.

INSPIRE.

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.

MW20

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

2

Requisition ID:R91488

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