Why Patients Need You
Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve
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 for biological therapeutics. Qualified candidates will deliver results in a fast-paced matrix-oriented setting as a contributor to marketing authorization applications for biologics. The role is in support of 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 to author and oversee documentation associated with early phase regulatory filings, data verification, method conversions and work directly with technical teams and subject matter experts.

It is your innovative scientific temperament that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
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, and reviewers of regulated documents such as methods descriptions, validations, in-process control strategy, and comparability sections.

Colleagues in this group are encouraged to be updated with current scientific trends, strategies, and technical aspects from conferences, international guidance documents, and the literature.

Attend project team and brainstorming meetings and present data.

Contribute to achievement of immediate work group goals and collaborate with other team members.

Support analytical outsourcing for BTxPS ARD as necessary.

Qualifications
Must-Have

Master's Degree with 2 years of experience or bachelor's degree with 3+ years of experience with interdisciplinary drug development teams and industrial experience supporting analytical strategies. 

Working knowledge of methods in support of product and process development and to assess the quality and characteristics of biotherapeutics.

Working knowledge of regulatory submissions and the eCTD format.

Proficiency with Microsoft Word is expected.

Experience with laboratory data systems

Provides attention to detail and good at documentation Method validation experience

Ability to extract relevant information from scientific literature, accurately record observations, facts, data and conclusions during experimental work or Good Manufacturing Practices {also cGMP} investigations

Good knowledge of fundamental organic chemistry, functional group recognition and compound characterization with some experience using spectroscopic and chromatographic techniques

Interact effectively with peers and leaders as part of a multi-disciplinary team

Effective verbal and written communication skills

Nice to Have

Direct experience working with FDA or other regulatory authorities for programs in late-stage clinical development or approved products.

Demonstrated technical writing skills, effective communication, and detail oriented are strongly desired.

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.

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Minimal travel may be required

Other Job Details

Work Location Assignment: Remote colleagues work from home 5 days a week or are field-based colleagues that are not affiliated with a Pfizer site.