Medical Writer (Manager) - San Francisco, CA | Biospace
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Medical Writer (Manager)

Pfizer Inc.

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Location:
San Francisco, CA
Posted Date:
9/23/2017
Position Type:
Full time
Job Code:
1614768
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Medical Writer collaborates with members of the clinical study team to prepare high-quality protocols, clinical study reports (CSRs), public disclosure synopses (PDS), and related clinical documents within agreed-upon timelines.

Responsibilities
  • Prepares, edits, and finalizes protocols, clinical study reports (CSRs), public disclosure synopses (PDS), and related clinical documents
  • Engages early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for CSRs
  • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Collaborates with clinicians, clinical scientists, statisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in CSRs
  • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
  • Works closely with the study team to reach consensus on time lines for deliverables
  • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments to ensure SOP and regulatory compliance
  • Understands the functions and roles within the study team and aligns with them in delivery of CSRs to meet project-related goals and to meet external results disclosure obligations
  • Manages all aspects of CSR production and ensures project delivery
  • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Ensures documents are generated in accordance with agreed internal processes and standards (e.g., Pfizer Global Document Style Guide), are submission ready, and are appropriately stored in agreed document management system
  • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
  • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
  • Align with department management to set strategy for meeting department goals

Requirements

Qualifications
  • At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
  • BS/BA +4 years, MS/MA +3 years of relevant medical writing experience in the pharmaceutical industry, especially writing CSRs in one or more of the therapeutic areas in which Pfizer has products.
  • An understanding of the drug development process
  • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
  • Knowledge of ICH and other regulatory guidelines; demonstrated ability to interpret and apply these guidelines to document writing
  • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
  • Experience in interacting with crossfunctional study team members
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
  • Utilizes a balanced approach to problems, using flexibility and persistence as appropriate
  • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.

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.

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.

Additional details:

  • This job is Pfizer Exempt US Grade: 9
  • Additional Location Information: Groton, CT; Collegeville, PA; New York, NY; Peapack, NJ; La Jolla, CA; San Francisco, CA; Remote
  • Eligible for Employee Referral Bonus