The Medical Writer collaborates with members of the clinical study team to independently interpret study results to prepare high quality protocols, clinical study reports (CSRs), public disclosure synopses (PDS) and related clinical documents within agreed-upon timelines.
- 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.
- 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, or PhD with 0 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 cross functional 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.
- Ability to accurately, comprehensively, and professionally communicate both verbally and in writing in English.
- Some travel (~5-10%) across GPD sites for staff management and face-to-face meetings.
- Ability to attend global teleconference calls that accommodate different time zones.
Position located at GPD site or remote work location. Primarily an office-based position involving computer work, attending meetings, making presentations, and participating in global conference calls that accommodate different time zones
Other Job Details:
- Last Date to Apply for Job: October 23rd 2020
- Eligible for Employee Referral Bonus: YES
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