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Manager, Medical Writing

Pfizer


Location:
Groton, CT
Date:
05/26/2017
Job Code:
1051069-1852
Pfizer
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Job Details

Job Title Manager, Medical Writing

JobID 1051069-1852

Location: Groton, CT

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



*Role Description*

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.



*Responsibilities*

*Prepares, edits, and finalizes protocols, clinical study reports (CSRs), public disclosure synopsis and related clinical documents*Engages early with team including participation in the review of mock and/or blinded tables, listings, and figures and narrative planning*Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in the final tables, figures, and listings, 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, pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in the CSR*Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed*Works closely with clinical study team to reach consensus on time lines for deliverables*Completes documents according to agreed-upon timelines and follows up with 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*Works with groups outside of CD&O, i.e. Regulatory, Publishing Coordinator, Study Management, Clinical Trial Disclosure., Medical Quality Assurance*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 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



*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 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.PHYSICAL/MENTAL REQUIREMENTS *Position located at GPD site or remote work location. Primarily an office-based position involving computer work, attending meetings, making presentations, participating in global conference calls that accommodate time zones. *Ability to professionally communicate both verbally and in writing in the English language. Can discuss clinical data succinctly and accurately with cross-functional lines, scientific staff from a range of disciplines, and all levels of managementNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Some travel (~5%) across GPD sites for face to face meetings, if necessary. Depending on location may need to accommodate global teleconference calls across different time zones.



*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.





*Manager, Medical Writing*
*Groton, Connecticut*
*1051069-1852*


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