Global Head of Medical Writing, Swiftwater, PA

Job description

Job Overview

Under the direction of the Global head of Medical Writing &Translation, Leads and manages a team of professional Medical Writers (MW) in France and US engaged in the planning, authoring, compilation, review, and approval of medical, scientific, regulatory documents supporting vaccine development and licensure. Works in close collaboration with the other managers in Clinical Programs and Clinical Sciences to accomplish business objectives. Represents the MW platform in key meetings to define platform strategy and provides guidance and leadership in development medical writing related processes. 

Responsibilities

Coordinates and ensures delivery of Medical Writing activities and deliverables

·  Plans and manages the day-to-day assignment of work to individual medical writing team members. This includes writing of clinical study protocols, study reports, Phases I-IV, informed consent documents, investigator's brochures, briefing packages and clinical CTD summary documents.
·  Ensures that MW complete all required documentation related to their work on clinical documents including filing required documents to the TMF.
·  Provides guidance on interpretation of ICH guidelines and regulations on authoring of clinical documents
·  Ensures proactive, timely reporting on progress of operational components (quality, compliance, performance), communicates operational opportunities and risks to the Global Head and other appropriate individuals within the Clinical Programs and Clinical Sciences organization.
·  Contributes to the development of the outsourcing strategy for the global platform
·  Identifies the needs for contracted resources or for outsourcing to CRO partners.
·  Ensures activities related to his/her platform are conducted with optimum quality and efficiency, meet global regulatory requirements, company SOPs, and are in alignment with the overall Clinical Sciences/Programs strategy and priorities

Responsible for the management of a global team of medical writers.

Leads and manages the Medical Writing team; responsible for recruitment, management and development of medical writers globally.

·  Focuses on developing skills and capabilities that support strategic goals and objectives of the organization.
·  Attracts, motivates and retains qualified staff to ensure the attainment of Medical Writing goals and objectives
·  Be engaged in the development of his/her direct reports
·  Coaches and mentors team members
·  Ensure training requirements are appropriately followed and tracked at the platform level

Process and Continuous improvement:

·  Leads/Contribute to the development of appropriate templates and guidelines to ensure a consistent and compliant approach to the writing of clinical documents.
·  Leads /Contributes on initiatives both at the SP and Group Level
·  Establishes culture of continuous learning and improvement
·  Stays abreast of new regulatory guidance and industry-wide initiatives that impact Medical Writing and recommends appropriate actions
·  Identifies process issues requiring resolution at the platform level and proposes solutions

Education/Experience

An advanced degree in Science with expertise in the writing of clinical regulatory documents used to support clinical development and licensure. Two to three years' experience directly managing medical writers engaged in the preparation of CTD submissions and other regulatory documents.

Mandatory

Management Experience

Medical Writing Expertise

Recommended

Knowledge of Vaccine Clinical Development is an asset.

Terms of employment

This is a full-time position and will require occasional international travel

What makes the position unique?

This position is global and has a high level of impact on the business by ensuring that clinical documents are prepared to high standards of quality and delivered in time to support clinical trials, marketing registrations, and other business objectives. They will manage and develop a group of experienced medical writers dedicated to bringing new vaccines to market. The positon also provides medical writing expertise to the Vaccines Clinical Department and drives process improvements.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.