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Senior Specialist, Regulatory Affairs
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.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
The Senior Specialist, Regulatory Affairs provides support to redaction operations and holds primary responsibility for ensuring the company’s compliance with transparency and privacy regulations by collaborating with product development teams to review documents with protected information and redact accordingly.
Under the supervision of the Director of Clinical Data Disclosure & Transparency, the position is accountable for:
- Leading the review and preparation of documents to ensure personal protect information is removed;
- Leading collaborative review with contributing authors and product development team to identify commercially confidential information in documents;
- Executing quality checks of documents including the completion of associated justification;
- Managing disclosure timelines and participating in submission planning management team meetings;
- Monitoring and escalating potential breaches in release of protected information;
- Providing input and feedback to the Standard Operating Procedures and Working Instructions for the preparation of documents for public release.
- Assist external data sharing efforts and operations.
- Bachelor’s degree in Life Sciences or related discipline
Required Experience and Skills:
- Minimum 5 years of pharmaceutical industry and/or clinical research experience.
- Proficient in the use of a Doc based system or similar Electronic Document Management system.
- Experience writing or knowledge of the content of drug and/or device study submission documents.
- Background and experience in the drug and/or device document submission process.
- Knowledge of the European Medicines Agency (EMA) and/or Health Canada publication of clinical information requirements.
- Highly organized and able to manage multiple projects simultaneously.
- Attention to detail and dedicated to excellence in all aspects of their work.
- Ability to work under pressure, and to work independently and collaboratively in a team environment.
- Excellent communication and stakeholder management skills.
- The ability to maintain a positive attitude under pressure.
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.
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:
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.
Flexible Work Arrangements:
1st – Day
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Number of Openings:
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Job posted: 2022-04-24