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Job Opening details:-
Company Name :- Merck
Position Name :-
Company Location :- Rahway, NJ
Job Category :- General
Full Job Description :-
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
The Medical Writing Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio. The Associate Clinical Technical Editor (CTE) is a member of the Medical Writing team who is responsible for quality control of clinical documents intended for submission to regulatory agencies.
In this role the Associate CTE will
Coordinate and perform our Company’s Quality Control (QC) process for clinical documentation that includes, but is not limited to, clinical protocols, investigator brochures, clinical study reports (including administrative appendices), patient narratives, and clinical modules of the common technical document. Oversight of external resources for QC may be required
Ensure documents comply with appropriate ICH and regulatory guidance.
Work collaboratively with internal and external medical writers, regulatory publishers, and project team members to deliver high-quality clinical documentation in a timely manner
Review and edit clinical documents in support of clinical development projects in multiple therapeutic areas and at various stages of development according to Our Company’s SOPs and guidelines to verify
Completeness and accuracy of information;
Accurate use of grammar and style;
Consistency of text with internal document data displays as well as external reference sources;
Application of format standards for electronic documents; and
Compliance with submission-ready standards.
Ensure consistent QC and good document practices are followed across internal authors, vendors, and external partners
Work within the document management system to ensure security and version controlled is maintained
Support the development, implementation, and periodic review of editorial management procedures
Support medical writers on the use of tools and technologies to facilitate efficient and compliant document delivery
The Associate CTE will also participate in the following:
Training as new tools and processes are implemented
Mentoring of new department members
Process improvement initiatives
Team Leading responsibilities
In this role the Associate CTE must demonstrate the following skills in the scope of quality control across therapeutic areas on a limited set of document types, including subject narratives and potentially other documents as assigned:
Complete fluency in reading and writing American English
Thorough understanding of the appropriate use of English-language grammar rules and American Medical Association Manual of Style rules
Ability to flawlessly verify accuracy of all data in documents
Ability to consistently apply all defined electronic format standards to documents
Technical expertise in systems used for document workflow (eg, RCAM, SharePoint)
Complete understanding of and strict adherence to all defined processes
Proficiency in mentoring other department members
Minimum required education:
Requires a BA/BS or equivalent and at least 2 years of experience in editing, preferably in the pharmaceutical and/or biotech industry. Proven skills in technical editing of clinical documents, preferred.
Additional skills and experience:
Experience in the use of a Doc base system or similar Electronic Document Management system
Excellent written English skills
High degree of organization and ability to manage multiple projects at any given time
Attention to detail and commitment to excellence in all aspects of the work
Ability to work under pressure and to work independently and collaboratively with teams
Excellent communication and interpersonal skills and ability to maintain a positive attitude under pressure
Advanced Microsoft Word skills (including the use of electronic Word templates) and Adobe Acrobat
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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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.
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.
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: No relocation
VISA Sponsorship: No
Flexible Work Arrangements: Remote Work
Valid Driving License:
Number of Openings: 1
Disclaimer : We have no legal responsibility over the details mentioned on our website. candidates are requested to check company profile before joining.
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