Technical Writing Director, Chemistry Manufacturing and Controls
(CMC) Global Regulatory Affairs Are you interested in leading a
team of technical regulatory writers and influencing global
Regulatory CMC strategies? If so, the Director, Regulatory Affairs
Chemistry Manufacturing and Controls (CMC) Technical Writing
position might be for you.
As Director of Regulatory CMC Technical Writing you will be
responsible for the leadership, strategic planning and management
of the CMC Technical writing function in alignment with business
goals. You will be accountable for results and are expected to
align activities with other functions to facilitate achievement of
corporate objectives. Our Chemistry Manufacturing and Controls
(CMC) Technical Writing function resides organizationally within
CMC Regulatory Affairs at GSK SED and provides writing execution
and strategy support for development of key regulatory CMC
documents across the site's portfolio of products. In this role you
will report to the Senior Director of CMC Regulatory Affairs.
This role will provide YOU the opportunity to lead key
activities to progress YOUR career, these responsibilities include
some of the following:
•Establish strategies for document authoring, contributing
strategically and scientifically at the project and/or team level,
directing external partners (i.e., CMOs) with regard to document
quality, and developing CMC Technical writing timelines, processes,
and working standards within budget.
•Analyze and determine document authoring resource needs,
proactively identifies issues and solutions, and sets timelines and
•Manage other CMC Technical writers, assesses performance and
performs individual reviews/career development plans
•Advise other CMC Technical Writing staff by providing guidance
and leadership for document development for regulatory filings and
coordinates the sections of more complex regulatory submissions,
including organization, content and resource requirements
•Ensure key messages are clear and consistent within and across
•Independently serve as the primary author of CMC documents and
lead writer for documents intended for Marketing Application
submissions to Global Health Authorities.
•Interpret and summarize complex data, including data across
multiple disciplines and sites
•Keep abreast of current industry standards and techniques
•Oversee development templates, workflows, in-house style guides
We are looking for professionals with these required skills to
achieve our goals:
BA/BS in scientific or technical discipline
10 or more years of pharmaceutical regulatory experience
Regulatory CMC Technical writing experience required in the
organization and format of ICH M3 (IND/IMPD, BLA/NDA/MAA, QOS)
Clinical phase specific CMC documentation experience including
experience with BLA/NDA/MAA registration requirements, post
approval supplements and variations.
Experience writing Module 2 QOS and Module 3 documents
If you have the following characteristics, it would be a
Ability to act decisively, adapt to a dynamic product
development environment and track diverse project
Exceptional communication and interpersonal skills
Excellent organizational and project management skills to
coordinate multiple projects
Strong expertise with Microsoft Word and submission
Proficient with Microsoft Excel, Project and Powerpoint
Our values and expectationsare at the heart of everything we do
and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity
along with Courage, Accountability, Development, and Teamwork. As
GSK focuses on our values and expectations and a culture of
innovation, performance, and trust, the successful candidate will
demonstrate the following capabilities:
Agile and distributed decision-making - using evidence and
applying judgement to balance pace, rigour and risk
Managing individual and team performance.
Committed to delivering high quality results, overcoming
challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in
Continuously looking for opportunities to learn, build skills
and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative,
motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing
trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for
a job at GSK, please contact the GSK Service Centre at
1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere
to Affirmative Action principles. This ensures that all qualified
applicants will receive equal consideration for employment without
regard to race, color, national origin, religion, sex, pregnancy,
marital status, sexual orientation, gender identity/expression,
age, disability, genetic information, military service,
covered/protected veteran status or any other federal, state or
local protected class.
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