Sr. Specialist, Non-clinical Pharmacology Document Writing

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Responsibilities:
  • Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support the development of therapeutic agents and vaccines.
  • This includes but is not limited to scientific writing, data verification, and formatting. Interact with colleagues from multiple areas, including discovery, regulatory affairs, project teams, and development functions.
  • Partner with scientists and management to produce and edit nonclinical pharmacology reports and submission documents.
  • Create documents that effectively and clearly describe research results, product candidates, and other information required for regulatory submissions.
  • Ensure documents comply with regulatory and business guidelines in terms of content, format, style, and structure.
  • Assist in managing document authors/reviewers interface with our Company's document system.


Skills:
  • Strong computer skills, especially MS Word
  • Excellent writing skills
  • Ability to accept and integrate input from diverse sources and work effectively across multi-disciplinary work teams
  • Good understanding of scientific/biology terminology
  • Enjoy working in a fast-paced environment
  • Good communication skills
  • Good organizational skills


Education Minimum Requirement:
  • PhD in biology, pharmacology, medicine, or related fields with 2+ years' experience, OR, MD degree with 2+ years' experience, OR MS with 5+ years' experience, OR BA/BS with 8+ years' experience.


Required Experience and Skills:
  • Strong writing skills and experience drafting study reports, scientific manuscripts, or scientific documents
  • Strong computer skills, especially MS Word


Preferred Experience and Skills:
  • A good understanding of therapeutic and/or vaccine development, including an understanding of the nonclinical aspects, e.g., pharmacology.
  • A good understanding of the content of regulatory filings for nonclinical pharmacology in the context of CTD, IND, IMPD, NDA/BLA/MAA.
  • American Medical Writers Association certification


MRLGCTO

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.

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

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

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., 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:

Flexible Work Arrangements:
Not Specified

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R150067