Senior Medical Writer

Site Name: USA - Maryland - Rockville Posted Date: Jun 16 2021 For the Senior Medical Writer position at GSK, we are seeking an individual who works directly with diverse stakeholders at different levels within GSK (e.g., Clinical Research and Development Leaders (CRDLs), Epidemiologists, Regional Medical Directors and Advisors, Study Delivery Leads (SDLs), Study Data Managers (SDMs), Biostatisticians, other Medical Writers and Publishing staff). This individual will establish a network of communication and will continuously build collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments. This position is based at our US Research and Development Center (RDC) in Rockville, Maryland, but remote working and flexible hours may be possible. Experience developing documents necessary for this position include clinical concept protocols/protocols, informed consents, clinical study reports, investigator brochures and documents supporting submission to regulatory authorities. As an individual responsible for Medical Writing deliverables, the Senior Medical Writer is expected to work on assignments independently, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The writer should be able to meet the quality standards of the global organization. The Senior Medical Writer is accountable for the final deliverable and is expected to work in matrix environment. This individual will also: 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 a minimum of 3 years of experience in medical writing. Possess flexibility to work efficiently across time zones (e.g., with colleagues in Europe and India). 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. Experience in basic immunology and area of assigned vaccine project. Experience in scientific methodology in the design, conduct and description of clinical research. Experience of how to analyze and describe clinical results. Experience in the organization of clinical study reports and scientific presentations. Experience in International Committee for Harmonization (ICH) / Good Clinical Practice (GCP). Experience in statistical principles used in clinical research. Proficiency in MS Word & Excel) and general computer literacy. Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD or equivalent (or another post-graduate degree with pharmaceutical industry experience). Why GSK? Our values and expectations are 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: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. 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. 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. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.