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Experience:
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Employment Type:
Full time
Posted:
3/1/2016
Job Category:
Science
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Managing Medical Writer Job
MSD | Rahway, New Jersey
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Job Description

Managing Medical Writer-CLI004611

Description

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.


The Managing Medical Writer (MMW) is a key member of the Medical Writing team who brings expertise and leadership qualities to the writing group. With both a people and project-facing orientation, the MMW is responsible for leadership of, and strategic and scientific contributions to the preparation of regulatory documentation in support of the clinical development pipeline. As an integral part of a clinical and/or study team, the MMW ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical regulatory documents using an electronic document management system. Must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.

May have overarching responsibilities for oversight of multiple clinical programs or disease areas. Directs teams in development of documentation roadmap (e.g., strategic program level overviews as well as details for particular deliverables, timelines, resources, expected deliverables, review cycles, issue escalation/mitigations, presentations to Sr. Management as needed), leads dossier preparation, and writes key documents and/or oversees the writing of others. Builds talent and capabilities of medical writing team members through proactive coaching, mentoring and development opportunities. Facilitates and collaborates with internal and external stakeholders in support of clinical documentation objectives. May include management of direct reports including assignment of resources, professional development and performance management. Leads or contributes to process improvement initiatives.

Qualifications

Education:

- Bachelor's Degree in the Life Sciences with 12 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- MS Degree in the Life Sciences with 10 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry OR
- PhD in the Life Sciences with 6 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry .

Required:

- Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of 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.
- A minimum of 2 years experience managing people, projects and/or the work of others.
- Provide leadership of and management for complex documentation projects and project teams of medical writers.
- Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
- Excellent oral (including presentation) and written communication, and project management skills.
- Awareness of pharmaceutical industry needs beyond clinical development.

Preferred:

- Demonstrated experience in process improvement.
- Active involvement in professional organizations.

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 staffingaadar@merck.com.

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.

Visa sponsorship is not available for this position.

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

EEOC Poster

EEOC GINA Supplement‹



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.


Job: Clinical Research - Clin Ops

Job Title:Principal Scientist, Clinical Operations

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-Upper Gwynedd, NA-US-MA-Boston

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 4

Company Trade Name:Merck

About MSD

MSD Ignition is a company built on Customer Satisfaction and Service. That is why all of our products go through regimented test procedures before they are ever packaged and shipped. MSD stands behind our products for one full year after purchase and we have an excellent repair department. Terms of Warranty and Service are as follows: Limited Warranty Autotronic Controls Corporation warrants MSD Ignition products to be free from defects in material and workmanship under normal use and if properly installed for a period of one year from date of purchase. If found to be defective as mentioned above, it will be replaced or repaired if returned prepaid along with proof of date of purchase. This shall constitute the sole remedy of the purchaser and the sole liability of Autotronic Controls Corporation to the extent permitted by law, the foregoing is exclusive and in lieu of all other warranties or representations whether expressed or implied, including any implied warranty of merchantability or fitness. In no event shall Autotronic Controls Corporation be liable for special or consequential damages. This warranty is only valid on products purchased from MSD Authorized Dealers.

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