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Job Information

Merck Senior Medical Writer, Oncology in Rahway, New Jersey

Job Description

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 .

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.

MW20

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:

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 at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

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:

5

Requisition ID: R84520

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