Pfizer

Regulatory Submission Professional

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Posted
April 30 2021
Ref
4812242
Position Type
Full Time
Organization Type
Pharma
Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Support submission ready process and records management program for the Department.
  • Responsible for formatting and assuring documentation associated with regulatory submission meets current regulatory specifications.
  • Provide advanced word processing support for documents included in submissions. This requires a highly competent knowledge of word processing (e.g. MSWord) and publishing (Adobe Acrobat) applications.
  • Support colleagues on use of submission templates, act as subject matter expert for current submission guidelines and any documentation needs.
  • Collaborate with functional lines and disciplines to safeguard documentation compliance and applicable submission filing activities.
  • Partnering with project teams and other customer groups (e.g., Managers, Cross functional teams, etc.) to provide advanced word processing support for documents included in submissions to ensure required regulatory meet business needs and are provided in accordance with agreed time and quality standards.
  • Accountable for database searches and contribute to documentation workflows.


Qualifications

Must-Have

  • Bachelor's Degree or minimum 5 years of demonstrated experience. A wareness of the functioning of the pharmaceutical industry (vaccine research and/or regulatory environment preferred) .
  • Strong IT skills: advanced use of MS Word, Adobe Acrobat. Knowledge of Documentum systems.
  • Relevant experience in electronic submissions build within the Pharmaceutical Industry.
  • Ability to understand complex issues with appropriate support, such as global and/or regional regulatory activities involved in the regulatory filing process.
  • Strong written and verbal communication skills.
  • Ability to work well with appropriate level of independence, appropriate level of supervision, and scientific and regulatory community.
  • Strong problem solving skills, organizational skills, and multiple projects flexibility. Ability to work well with the team.
  • Detail oriented, precise in oral and written communication. Must be able to present information effectively, both orally and/or in writing, in a concise, logical, and persuasive manner.
  • Work well under pressure and a demanding workload.


Nice-to-Have

  • Strong problem solving abilities.



Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Regulatory Affairs

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