Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Primary responsibilities include preparation of nonclinical pharmacology regulatory document submission sections and nonclinical pharmacology reports to support the development of biological medicinal products. Activities include but are not limited to gathering of information/data, technical writing, editing, and formatting of nonclinical pharmacology reports and regulatory summary sections. Documents are expected to clearly and concisely describe research results and product candidates, and to comply with regulatory submissions standards and business guidelines in terms of content, format, style, and structure. Qualifications:
- PhD in biochemistry, pharmacology, medicine, or related fields with experience in biopharmaceutical R&D nonclinical writing, OR, MD degree with experience in biopharmaceutical R&D nonclinical writing, OR MS with 5 years of experience in biopharmaceutical R&D nonclinical writing, OR BA/BS with 10 years of experience in biopharmaceutical R&D nonclinical writing
- Experience as a primary author in drafting nonclinical pharmacology reports and summary sections of regulatory filings
- A strong scientific background in development of therapeutic biologics, including a strong understanding of non-clinical in vitro and in vivo pharmacology
- A solid understanding of the content of regulatory filings (CTD, IND, IMPD, BLA/BAA/CTA and related ICH guidelines)
- Strong scientific background, e.g., biology, pharmacology, or biotechnology and understanding of scientific, biological, and biotechnology terminology
- Excellent writing and communication skills
- Good organizational skills and attention to detail
- Ability to accept and integrate input from diverse sources and work effectively across multi-disciplinary work teams
- Enjoy working in a fast-paced environment
- Strong computer skills, especially MS Word
- At least one year of experience with non-clinical pharmacology writing in the regulated biopharmaceutical industry
- Familiarity with electronic publishing and requirements
- Experience with Documentum
- American Medical Writers Association certification
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
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