Medical Writer Submission Lead (Director)

Org Marketing Statement

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description

* Autonomeously develops and leads the medical writing strategy to support Clinical teams with the creation of submission dossiers

* Builts and leads a team of medical writers to support the Clinical teams

* Creates writer submission processes for the Clinical team that are not already covered by other groups and by applying lessons learned from other medical writing leads/teams

* Aligns activities with the broader submission processes and determines efficiencies

* Actively engages in cross-functional clinical teams and provides deliverables within specified timelines.

* Serves as single point of accountability for coordination of document content, writing, and reviews.

* Determines writing staffing needs and interview candidates to support medical writing for submission dossiers.

* Represents medical writing at Submission Steering Committee meetings

* Creates and conducts training for incoming writing team and Clinical team members

* Drives writing across the clinical lines (clinical, stats, clin pharm). Ensures consistency across various submissions for the asset (e.g. , US/EU/PMDA) as well as consistency across the biosimilars portfolio with concurrent submissions.

Responsibilities

* High-level strategic medical writer with therapeutic expertise who drives the writing and coordination of high quality written presentations of Common Technical documents compliant with regulations, ICH guidelines, and corporate SOPs.

* Leads the story boarding process (drive creation of the story, align functions to support) and creates the introduction to the dossier.

* Authors documents (such as BPD2 submissions, key sections of the Investigator's Brochure, the Annual Safety rReports and Core Data sheet, etc), pulls in and aligns contributions from others/cross-functional teams.

* Ensures key messages and document style are communicated to authors and team to ensure consistency within and across different documents.

* Communicates resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.

Qualifications

Education and Experience:

* Minimum requirement: Life science background (eg, MD, DVM, PharmD, PhD, MSc, BSc or equivalent)

* 10+ years experience in pharmaceutical development, ideally in safety, regulatory or clinical areas, including 5+ years of experience in medical writing.

* Biosimilar experience ideal.

Skills:

* Language skills. High fluency in written English and strong functional fluency in spoken English.

* Excellent track record of scientific writing skills, including the ability to summarize and interpret complicated data efficiently, consicesly and persuasively.

* Analytic skills. Ability to independently examine data, think through results, resolve discrepancies, analyze, interpret and apply new clinical data with a focus on the key messages

* Strong organizational skills and ability to prioritize multiple projects and meet deadlines

* Supervisory experience either as a direct manager or within a matrix setting is desirable

* Excellent understanding of Principles of Clinical & Clinical Trials Operations

* Excellent interpersonal skills with business acumen awareness. Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Abilty to work well with all levels and roles in cross-funcitonal, global teams.

* Proficiency with computer applications (e.g., OC-RDC, MS Excel, MS Outlook, MS Word)

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.