GSK is seeking a motivated Associate Director of Medical Writing who is passionate about science and eager to contribute to vaccine development at a global organization. This important role is an opportunity to ensure the preparation of quality documents in support of one or more exciting vaccine development programs.
This position is based at our US Research and Development Center (RDC) in Rockville, Maryland, but remote working may be possible for those in other geographic locations. 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.
The chosen candidate must be flexible working efficiently in a matrix environment across time zones (EST) (e.g., with colleagues based in the United States, Europe, and India)
This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities of the role include the following:
Why you? Basic Qualifications:
- Oversees, coordinates and/or writes documents of a consistently high quality to support operational and strategic goals.
- Provides expert knowledge to ensure deliverables (with inputs from the matrix team) are of consistent high scientific standards, with a logical flow in the presentation and interpretation of information throughout the project (inconsistencies should be escalated so risks may be transparently assessed).
- Promotes and provides information support in terms of strategic input to GSK Vaccines' Clinical Development Plans, regulatory submission writing and responses to questions from regulatory authorities.
- Tracks key performance indicators and leads implementation of continuous improvement through exercises such as lessons learned. This includes implementing best practices of/lessons learned from other writing teams and RDCs.
- Overviews project workload to anticipate bottle necks and specific resource issues. Resource gaps (or surplus) are communicated to facilitate even distribution of work throughout the scientific writing function.
- Assesses and escalates risks to the appropriate level in addition to communicating opportunities the manager.
- Resolves conflicts in priority or opinions from reviewers/approvers to ensure alignment of stakeholder (including the Clinical Research and Development Leader, [CRDL]).
- Promotes knowledge sharing knowledge of the Scientific Writers in the project. Coaches and develops Associate Scientific Writers and Scientific Writers in all areas of accountabilities and ensure their integration into the team / company. Give information on training needs of his/her team to the Manager, Scientific Writing. Provides mentorship which develops skills and strengths of junior/newly hired members of the team as well as Provide feedback/information to his/her team members on projects and specific activities.
- Builds capability by refining and expanding activities to optimize benefits of co-location or remote working. This may include new areas of regulatory support or building more robust quality/consistency in a transversal environment. Where the AD coordinates other writers, the work assigned should match the capability of the individual, with more experienced writers assigned more complex or novel tasks.
- Ensures compliance with legal, quality and other regulatory standards through management monitoring and KPI reporting, proactively escalating risks to facilitate mitigation.
We are looking for professionals with these required skills to achieve our goals:
- 5+ years of medical writing and project management experience
- Masters degree in a science/medical field
- Experience working with clinical trials
- Experience executing market-size and market-share strategies
- Experience working with basic immunology and areas of assigned vaccine project.
- Experience working with scientific methodology in the design, conduct and description of clinical research
- Experience analyzing and describing clinical results.
- Experience working with the International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP)/Regulatory requirements
- Experience working with statistical principles used in clinical research
If you have the following characteristics, it would be a plus:
- Good understanding of complex scientific information & skills to communicate information to various target audiences
- Excellent organization skills to coordinate and manage geographically dispersed multicultural teams
- Understands the organization of scientific documents
- Possesses computer skills and general computer literac
- Familiarity with navigating electronic Trial Master Files (eTMFs) (i.e., Veeva Vault)
- Possess strong verbal and written communication skills
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant 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.
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