Pfizer

Document Specialist, Oncology

Employer
Pfizer
Location
Boulder, Colorado
Salary
Competitive
Posted
November 21 2021
Ref
4830151
Discipline
Life Sciences, Oncology
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY

The Document Specialist for Boulder will be dedicated to Boulder compound(s) and will assist the Clinical, Nonclinical, and Regulatory Teams with the authoring, formatting, publishing, and GDMS activities associated with regulatory submissions. This position requires coordination across clinical and nonclinical lines, liaising with Boulder toxicology, pharmacology, ADME and clinical leadership as well as with regulatory to ensure rapid, accurate and timely submissions to health authorities.

ROLE RESPONSIBILITIES
  • Collaborate with Boulder functional leads, regulatory and partner lines where appropriate to align expectations and establish action plans to prepare submission documentation.
  • Serve as GDMS document coordinator for Boulder toxicology, pharmacology, ADME and clinical.
  • Support the authoring on function specific contributions to IND/IB/NDA packages, clinical trial protocols, protocol amendments, ICDs, CSRs DSURs and annual reports.
  • Primary (sole) author/compilator for initial Investigator's Brochures and any IB updates.
  • Provide guidance on document and data quality requirements to meet regulatory standards.
  • Key SME and responsibility for submission formatting requirements, document management workflows and publishing.
  • Represent Boulder functional lines on document management tools, systems and process improvement initiatives.


QUALIFICATIONS
  • 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 and 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.


PHYSICAL/MENTAL REQUIREMENTS
  • 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 and able to thrive in an environment with frequent interactions with a variety of different people


OTHER JOB DETAILS

Eligible for Employee Referral Bonus

For roles based in Colorado:

The annual base salary for this position ranges from $75,700.00 to $126,100.00. In addition, this position offers an annual bonus with a target of 10.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Pfizer 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.

Regulatory Affairs