Pfizer Technical Writer, Analytical Research and Development in St Louis, Missouri
The qualified candidate will be a technical writer in an analytical organization (Analytical R&D) seeking to lead the industry in technologies applied to advance biotechnologically-derived products to the market through innovation and delivery of cutting edge analytical testing. The qualified candidate will be part of an organization that focuses on late stage analytical support group for biological therapeutics. The group is responsible for the validation and late-stage analytical lifecycle management of quality controlled methods as they are established in commercial manufacturing sites. Qualified candidates will deliver results in a fast paced matrix-oriented setting, and be a technical writer and contributor to marketing authorization applications for biologics. The role is in support of products and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates, and therapeutic proteins, in late-stage clinical development. The candidate will work across analytical functions, projects, and global sites. Candidate will primarily author and oversee documentation associated with regulatory filings.
MINIMUM: B.A. / B.S. in biology, biochemistry, immunology, molecular biology, analytical chemistry, or related field
DESIRABLE: M.S. in above, plus coursework in biochemistry, quantitative analysis.
MINIMUM: M.S. with two years of experience or B.A./B.S. with five years of experience with interdisciplinary drug development teams and industrial experience supporting analytical strategies and methods in support of product and process development and to assess the quality and characteristics of biotherapeutics. Demonstrated technical writing skills, effective communication, and detail oriented are strongly desired. Experience with regulatory submissions and method validations and method transfers to commercial manufacturing receiving labs. Proficiency with Microsoft Word is expected.
DESIRABLE (one or more areas): Direct experience working with FDA or other regulatory authorities for programs in late-stage clinical development or approved products. Proficiency with all Microsoft Office products and knowledge of electronic document systems is desired. Able to deliver results in a fast paced environment and effective communication to project teams.
OTHER ATTRIBUTES DESIRABLE:
Desire to train and develop colleagues, comfortable delegating
Change agile, functional in a fast-paced team environment where multi-tasking required
Enthusiastic about communicating to a broad range of stakeholders (from novices to experts) and seeking agreement in complex situations
Curiosity about seeking and applying current relevant scientific literature
This position is for technical writing of analytical sections in regulatory submissions. Candidates, therefore, should have in-depth scientific knowledge of a wide array of analytical methods, and their application in the development of biologics. They will be responsible for the authoring and timely review of many analytical sections in support of subject matter experts and late stage project teams.
Colleagues in this group are expected to collaborate and develop analytical filing strategies with cross-functional analytical teams across many sites in the United States and Europe. These teams are responsible for the planning, coordination, and execution of analytical support for late stage programs.
Qualified candidates will serve as technical writing resource for the department and project teams. Individuals in this group will be the primary authors, reviewers, and data verifiers of regulated documents such as methods descriptions, validations, and comparability exercises.
Colleagues in this group are encouraged to be updated with current scientific trends, strategies, and technical aspects from conferences, local meetings, and the literature.
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.
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Additional Offer Details:
Additional Location Information : St. Louis, MO
Eligible for Employee Referral Bonus
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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.