The Rare Disease Research Unit (RDRU) Document Specialist will provide guidance and assistance to RDRU project teams, with respect to authoring, formatting, publishing, and global data management system (GDMS) activities, to ensure rapid, accurate and timely submissions to regulatory authorities. The Document Specialist will serve as the RDRU subject matter expert (SME) on regulatory document preparation requirements, electronic documentation management systems and proprietary company MS Word submission templates. ROLE RESPONSIBILITIES
- Key subject matter expert responsible for regulatory submission formatting requirements, document management workflows and publishing.
- Collaborate with RDRU project teams where appropriate to align expectations and establish action plans to prepare submission documentation.
- Train and support RDRU scientists in the writing of Research Study Reports.
- Serve as RDRU Global Data Management Systems document coordinator.
- Provide guidance on document and data quality requirements to meet regulatory standards.
- Represent RDRU on document management tools, systems, and process improvement initiatives.
- Responsible for tracking of RDRU publications and external engagements.
- BA or BS in life sciences or related field.
- Five years pharmaceutical experience.
- Document formatting and publishing experience is required.
- Previous medical and/or technical writing experience is desirable.
- Outstanding written and oral communication skills with demonstrated ability to communicate well across business lines.
- Previous experience with document management, training, and archival systems such as, Adobe Acrobat, Microsoft Office, SharePoint is required.
- Knowledge of regulatory submission document principles and requirements is desirable.
- Familiarity with scientific terminology and good understanding of the drug development process.
- Experience managing a complex workload and conflicting timelines in a matrix environment.
- Ability to work independently as well as part of a team.
- High proficiency with computer and software applications.
OTHER JOB DETAILS
- Ability to work significant hours in front of a computer screen.
- Individual must have mental capabilities to allow tracking and completion of multiple tasks in parallel.
- Thrives in an environment with frequent interactions with a variety of different people/stakeholders.
Eligible for Employee Referral Bonus
#LI-PFEPfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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.