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329 million people suffer from COPD worldwide. A further 235 million suffer from asthma. We are on a journey to help everyone breathe better and live the life they want.
We have three open positions for this role! It is a great opportunity to work in a therapy area with an exciting pipeline of products across a broad range of respiratory conditions; join an enthusiastic and dedicated team; make a difference to people with respiratory illnesses.
The successful candidates will provide support and expert scientific / clinical advice in the planning, development, and implementation of clinical development programs serving as a Clinical Investigative Leader (CIL) to help further establish the leadership position of the company in the respiratory field.
• Authors clinical protocols, model informed consents and clinical study reports for pre-C2MD Respiratory Studies.
• Ensures authored clinical documents meet SOP/Document Standard requirements
• With Clinical Operations manages smooth running of clinical trials.
• Accountable for authoring end-of-study reports and publication of results
• Other writing responsibilities may include: investigator brochures, clinical summary documents or other clinical components of regulatory submissions, answers to regulatory authority questions, abstracts, posters, presentations for symposia and conferences, manuscripts and clinical sections of IND and annual reports.
• Participates in review of analysis plan and advises on required tables
• May contribute to setting up advisory boards including slide preparation, taking minutes and also slide preparation for FDA advisory committee
• Develops and maintains effective working relationship and facilitates communication between Medical Monitor, Clinical Operations, Regulatory, Statistics and other groups as appropriate
• Maintains an understanding of internal and external regulatory requirements relevant to provision of clinical documentation for regulatory files
• Serve as an active matrix team member by providing guidance and direction to peer Medics and scientists to ensure the successful achievement of the Respiratory TA's goals and milestones
• Actively participate in the development of scientific talent in the organization. Provide guidance and coaching to team members.
• Bachelor’s degree in life sciences or related discipline
• Minimum of 6 years of direct experience in running clinical trials (industry/hospital environments)
• Competent scientific writing skills
• Ability to travel to fulfill needs of role
• Doctorate degree such as a PhD or PharmD
• Experience with outsourcing to Contract Research Organizations
• Respiratory clinical trial experience
• Experience managing advisory boards, preparation of advisory committees and managing publication of clinical trials
• Able to operate in a complex organizational environment
• Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings
• Understands the necessity of a strong partnership with colleagues e.g. Clinical Operations, Regulatory, and Safety
• Able to prioritize competing demands for workload
• Comfortable with being personally accountable
• Ability to strike proper balance between independent work and team interaction; good team player in a cross functional team
• Proactively identifies problems and recommends solutions
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
We want to help people do more, feel better, live longer
We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Across the US, we employ more than 15,000 people who strive to help others do more, feel better and live longer. This work starts one person, one community, and one story at a time.
As a science-led, global healthcare business with clear values, we offer countless opportunities for people at various stages of their careers. On-the-job learning and rewarding individual contributions are extremely important to us. We believe in creating an inclusive and safe working environment and supporting our employees to help their communities.
You may apply for this position online by selecting the Apply now button.
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GSK is an Equal Opportunity/Affirmative Action Employer. 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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