Technical Writing Director, Chemistry Manufacturing and Controls (CMC) Global Regulatory Affairs
- Weston, MA
Site Name: USA - Massachusetts - Waltham
Posted Date: Dec 2 2020
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 processes
•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 documents.
•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 and SOPs
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 plus:
- Advanced degree
- Ability to act decisively, adapt to a dynamic product development environment and track diverse project budgets/resources
- Exceptional communication and interpersonal skills
- Excellent organizational and project management skills to coordinate multiple projects
- Strong expertise with Microsoft Word and submission templates
- 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 teams.
- 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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