ViiV Healthcare
Medical Writing and Clinical Submissions Associate Director Job at ViiV Healthca
ViiV Healthcare, Durham, NC, United States, 27701
ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV Healthcare is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on for the prevention and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in prevention, treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated.
ViiV Healthcare has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic.
We are aware of how much is at stake for those at-risk or affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV Healthcare isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference.
While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV Healthcare, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities.
Are you looking for a leadership role that allows you to lead strategy and accelerate regulatory/clinical submission documents and enhance the medical writing process? If so, this Scientific & Medical Writing Manager role could be an ideal opportunity to explore.
As a Medical Writing and Clinical Submission Associate Director, you will be responsible for applying scientific and operational expertise, and leadership in a matrix organization to design and deliver high quality, fit for purpose clinical documents and key organizational process improvements relating to clinical documents including submissions.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
The annual base salary for new hires in this position ranges from $142,171 to $192,349 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee.
Why Us?
At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.
We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.
Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.
If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
ViiV 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
ViiV 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 ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. 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 ViiV. ViiV 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, ViiV may be required to capture and report expenses ViiV 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 ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site.
ViiV Healthcare has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic.
We are aware of how much is at stake for those at-risk or affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV Healthcare isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference.
While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV Healthcare, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities.
Are you looking for a leadership role that allows you to lead strategy and accelerate regulatory/clinical submission documents and enhance the medical writing process? If so, this Scientific & Medical Writing Manager role could be an ideal opportunity to explore.
As a Medical Writing and Clinical Submission Associate Director, you will be responsible for applying scientific and operational expertise, and leadership in a matrix organization to design and deliver high quality, fit for purpose clinical documents and key organizational process improvements relating to clinical documents including submissions.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
- Serve as the Clinical Submission/MW Asset Lead by providing key contributions to clinical strategy, including knowledge, and understanding of regional and global requirements for delivering clinical/regulatory documents to regulatory authorities.
- Lead a team to develop MAAs, NDAs, Supplements (sNDA/Type 2 variations), CSRs, INDs, PIPs/PSPs, ICFs, DSURs, protocols, Briefing Packages, Agency Responses and other scientific and regulatory documents for submission to regulatory authorities.
- Effectively organize complex content and arguments in clinical/ regulatory documents.
- Effectively lead and work within a matrix environment in strategic planning and production of clinical/ regulatory documents to support regulatory submissions worldwide, including new chemical entities.
- Successfully plan and implement submissions independently or in conjunction with the MW Director. Provides guidance to submission teams in development of detailed submission plan.
- Demonstrates an ability to quickly assess complex situations and identify issues, apply scientific, operational and submission development knowledge to implement effective solutions.
- Motivate, influence, and manage direct reports, contract workers, other team members and senior stakeholders to effectively author, contribute to and review documents.
- Identify need for external resource support. Negotiate timelines, cost, and onboard external medical writing vendors/Clinical Research Organizations (CROs).
- Focus on process improvement or innovative solutions including technology or AI for achieving accelerated timelines as necessary.
- Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix, ensuring standards are proactively applied across a submission.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Life Sciences.
- 5+ years of experience leading activities or components of a project to meet business and regulatory writing submission needs.
- 5+ years of experience scientific or medical writing experience specifically within the biotech/pharmaceutical industry.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- PhD, PharmD, MPH, MS, or other post-graduate degree
- Highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at senior level.
- Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
- Ability to effectively lead and manage projects of increasing scope and complexity.
- Demonstrated familiarity with the role of other disciplines contributing to the overall drug development program.
The annual base salary for new hires in this position ranges from $142,171 to $192,349 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee.
Why Us?
At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.
We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.
Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.
If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
ViiV 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
ViiV 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 ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. 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 ViiV. ViiV 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, ViiV may be required to capture and report expenses ViiV 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 ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site.