Senior Medical Writer

Site Name: USA - Maryland - Rockville Posted Date: Nov 17 2021 Are you passionate about science and eager to contribute to vaccine development at a global organization? Have you considered a career in medical writing? GSK is seeking a motivated senior medical writer to ensure the preparation of quality documents in support of our vaccine development programs. As a Senior Medical Writer, you will be expected to work on assignments independently, facilitating delivery of quality written documents that adhere to the standards of the global organization through proactive coordination of stakeholders to build content. The Senior Scientific Writer is accountable for the final deliverable and is expected to work in matrix environment. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Contribute to documents and activities to be included in registration files. Author clinical documents supporting vaccine studies following defined templates. Ensure the consistency and quality level of all documents that are issued. Actively participate in all aspects of document development planning, coordination and review meetings to integrate and address stakeholder comments. Have the ability to work on a minimum of 2-3 assignments simultaneously. Proactively raise and discuss concerns/ issues in an open and timely manner and within the global team at GSK Vaccines to promote high scientific standards by pointing out any potential inconsistencies or inaccuracies and proposing alternative wording or strategies. Have familiarity with navigating electronic Trial Master Files (eTMFs), i.e., Veeva Vault. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Post-graduate degree in life sciences or medical background or equivalent expertise. 3+ years of medical writing experience or equivalent transferrable skills. Experience in basic immunology and area of assigned vaccine project. Experience in scientific methodology in the design, conduct and description of clinical research. Experience in analyzing and describing clinical results. Experience in computer skills (Proficiency in MS Word & Excel) and general computer literacy. Preferred Qualifications: If you have the following characteristics, it would be a plus: Possess strong verbal and written communication skills Demonstrate a thorough understanding of clinical trials Be flexible working efficiently in a matrix environment across time zones (e.g., with colleagues based in the United States, Europe, and India), Understands the organization of clinical study reports and scientific presentations. Possesses working knowledge of International Committee for Harmonization (ICH) / Good Clinical Practice (GCP). Possesses good working knowledge of statistical principles used in clinical research. Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. 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