Scientific Writer

Glaxosmithkline
Remote or Rockville, MD
Are you a recent graduate of a doctorate program in a scientific discipline or pursuing a career change in research? Have you considered a career in medical writing? GSK is seeking someone with strong communication skills who is curious about vaccine development. As a global organization, we offer exciting mentoring and professional development opportunities..

The Scientific Writer 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.

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 registrationfiles.

+ 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.

+ Proactively raiseand discuss concerns/ issues in an open and timely manner andwithin the global team at GSK Vaccines to promote high scientific standardsby pointing out any potential inconsistencies or inaccuracies and proposing alternative wording or strategies.

**Why you?**

**Basic Qualifications:**

We are looking for professionals with these required skills to achieve our goals:

+ Master's degree in life sciences or medical background or equivalent expertise

+ Experience in scientific methodology in the design, conduct and description of clinical research.

**Preferred Qualifications:**

If you have the following characteristics, it would be a plus:

+ PhD or equivalent

+ Excellent command over English language (verbal and written).

+ Good understanding of complex scientific information & skills to communicate information to various target audiences

+ Excellent organization skills to coordinate and collaborate with geographically dispersed multicultural teams

+ Understands the organization of scientific documents.

+ Possesses computer skills and general computer literacy.

**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.

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 (http://fortherecord.payments.us.gsk.com/content/hcppaymenttransparency/en/hcppayments/payments.html) site.

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .

Lead Scientific Writer (Vaccines)

Glaxosmithkline
Remote or Rockville, MD
Site Name: USA - Maryland - Rockville, New York City TSA, USA - District of Columbia - Washington Dc, USA - Florida - Miami, USA - Georgia - Atlanta, USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence

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 Lead Scientific Writer to ensure the preparation of quality documents in support of our vaccine development programs.
The ideal candidate will:

* Possess strong verbal and written communication skills with a minimum of 5 years of medical writing and project management experience;
* Demonstrate a thorough understanding of clinical trials; and
* Be flexible working efficiently in a matrix environment across time zones (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, these responsibilities include some of the following…

* 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 lead writer 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

* Master's degree in life sciences or medical background or equivalent expertise
* Three or more years experience of executing market-size and market-share strategies
* Three or more years experience in basic immunology and area of assigned vaccine project.
* Three or more years experience in scientific methodology in the design, conduct and description of clinical research.
* Three or more years experience in analyzing and describing clinical results.
* Three or more years experience utilizing and implementing International Committee for Harmonisation (ICH) / Good Clinical Practice(GCP)/Regulatory requirements.
* Three or more years implementing and utilizing statistical principles used in clinical research

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

* PhD or equivalent
* Five or more years experience of scientific writing or equivalent skills.
* Experience leading projects and mentoring staff
* Excellent command over English language (verbal and written).
* 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 literacy.
* Familiarity with navigating electronic Trial Master Files (eTMFs) (i.e., Veeva Vault)

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.

* This is a job description to aide in the job posting, but does not include all job evaluation details.
* LI-GS

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 site.

Scientific Writer

Glaxosmithkline
Remote or Rockville, MD
Site Name: USA - Maryland - Rockville

Posted Date: Jan 7 2022

Are you a recent graduate of a doctorate program in a scientific discipline or pursuing a career change in research? Have you considered a career in medical writing? GSK is seeking someone with strong communication skills who is curious about vaccine development. As a global organization, we offer exciting mentoring and professional development opportunities..

The Scientific Writer 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.

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.
* 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

* Master's degree in life sciences or medical background or equivalent expertise
* Experience in scientific methodology in the design, conduct and description of clinical research.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

* PhD or equivalent
* Excellent command over English language (verbal and written).
* Good understanding of complex scientific information & skills to communicate information to various target audiences
* Excellent organization skills to coordinate and collaborate with geographically dispersed multicultural teams
* Understands the organization of scientific documents.
* Possesses computer skills and general computer literacy.

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.

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.

Be the first to see new jobs

Engineering - Future Leaders Program, US - 2022

Glaxosmithkline
Rockville, MD
Site Name: USA - North Carolina - Zebulon, USA - Maryland - Rockville, USA - Pennsylvania - King of Prussia
Engineering - Future Leaders Program, US - 2022

Future Leaders Graduate Programme - Engineering

Education required: BS degree in Engineering - Mechanical Engineering, Electrical Engineering, Chemical Engineering, Biochemical Engineering, Industrial Engineering, Automation Engineering or Control Systems Engineering Majors. Graduation by Spring/Summer 2022.

Language requirement: Written and spoken fluency in your native language and English

Other requirements: Willingness to be geographically mobile throughout rotations

Start date: September 2022

* You can apply to only one Future Leaders Graduate Program in the U.S.

Application deadline: We recommend you apply as soon as possible, because we accept ongoing applications and offer positions on a first come, first served basis.

Want to solve some of the world's biggest health challenges?

The aim of this programme is to develop the future pharmaceutical supply chain engineering, operational and technical leaders.

We're looking for highly motivated engineering graduates who are keen to develop into our next engineering leaders. You will be energised by the thought of being part of our engineering team, ensuring we have the latest, safe, efficient and reliable equipment to deliver billions of packs of life-saving medicines to patients every year.

Develop your career

Over three years and three rotations, our Future Leaders Graduate Programme will challenge and support you to grow professionally and personally. You'll receive a generous development budget to accelerate your learning. You'll get to meet senior leaders and network with other graduates from across GSK. Which all adds up to a role that's designed to transform talented engineers into key, senior figures.

What will you do?

* Project management of new equipment from design to installation and commissioning
* Capital project execution
* Continuous Improvement: Increase manufacturing efficiencies through analysing machine data, root causing breakdowns and identifying improvements that increase equipment performance.
* Design and feasibility of new solutions and projects
* Reliability engineering looking at equipment uptime and availability
* Automation design, programming, troubleshooting, and management
* Safety & Ergonomic initiatives
* Provide focus on energy management and sustainability projects
* Keep abreast of cutting-edge technologies in precision engineering
* Work towards Professional Engineer status

You'll need:

* A relevant engineering degree
* Team player with the ability to work with and build relationships with key stakeholders
* Excellent communication skills and a gift for solving problems
* To be a self-motivated and proactive graduate who is keen to develop and learn.
* To be enthusiastic and driven to succeed.
* To be analytical and process-driven with excellent attention to detail.
* A genuine interest in the healthcare industry
* A desire to progress professionally to professional engineer status and into senior leadership roles

Our Future Leaders programme is designed to accelerate the development of graduates who don't have significant experience in the area to which they're applying. Of course, many graduates who join the program have worked while studying or after graduation. If you've already worked in a professional role in your sector, you're welcome to apply, but you may also want to look at direct entry roles in our businesses.

Benefits include:

* A competitive salary
* An annual bonus based on company performance
* Relocation Allowance (eligibility will be confirmed once your first location is confirmed)
* Access to healthcare and well-being programs, savings programs, time off and childcare support
* Employee recognition programs, which reward exceptional achievements
* Long-term incentives through shared ownership link your rewards to our longer-term performance
* A generous training budget
* On-the-job experience and formal and informal training and development, delivered through a mixture of coaching, mentoring and formal training programs

Get to grips with our recruitment process

You'll find hints, tips and guidance on our recruitment process on our website -

Apply now for our Early Talent programmes | GSK

We recommend you apply as soon as possible, because we accept ongoing applications and offer positions on a first come, first served basis.

We have changed the way we recruit in light of the COVID-19 pandemic, you can learn more about how our practices have adapted here.

Apply now

#ManufacturingandSupplyFLP

We're 100% open to all talent

We're 100% open to all talent - whatever your gender, marital status, religion, age, colour, race, sexual orientation, nationality or disability. We want to recruit the right people for GSK from the widest possible backgrounds, so we can better serve the diversity of our patients and consumers. And also because it's the right thing to do.

You can learn more about Inclusion and diversity at GSK here.

Need help with your application?

Please email us at AM.EarlyTalentRecruitment@gsk.com and let us know how we can help you. Or email us your number and we'll call you back. We'll make all reasonable modifications to support you throughout the recruitment process and we'll treat all information you give us in confidence. Please get in touch to help us process your application as soon as possible.

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 site.

Lead Scientific Writer (Vaccines)

Glaxosmithkline
Remote or Rockville, MD
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 Lead Scientific Writer to ensure the preparation of quality documents in support of our vaccine development programs.
The ideal candidate will:

+ Possess strong verbal and written communication skills with a minimum of 5 years of medical writing and project management experience;

+ Demonstrate a thorough understanding of clinical trials; and

+ Be flexible working efficiently in a matrix environment across time zones (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, these responsibilities include some of the following..._

+ 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 lead writer 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.

**_Why you?_**

**Basic Qualifications:**

_We are looking for professionals with these required skills to achieve our goals:_

+ Master's degree in life sciences or medical background or equivalent expertise

+ Three or more years experience of executing market-size and market-share strategies

+ Three or more years experience in basic immunology and area of assigned vaccine project.

+ Three or more years experience in scientific methodology in the design, conduct and description of clinical research.

+ Three or more years experience in analyzing and describing clinical results.

+ Three or more years experience utilizing and implementing International Committee for Harmonisation (ICH) / Good Clinical Practice(GCP)/Regulatory requirements.

+ Three or more years implementing and utilizing statistical principles used in clinical research

**Preferred Qualifications:**

_If you have the following characteristics, it would be a plus:_

+ PhD or equivalent

+ Five or more years experience of scientific writing or equivalent skills.

+ Experience leading projects and mentoring staff

+ Excellent command over English language (verbal and written).

+ 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 literacy.

+ Familiarity with navigating electronic Trial Master Files (eTMFs) (i.e., Veeva Vault)

**_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.

**_*This is a job description to aide in the job posting, but does not include all job evaluation details._**

**_*LI-GS_**

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 (http://fortherecord.payments.us.gsk.com/content/hcppaymenttransparency/en/hcppayments/payments.html) site.

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .

Associate Microbiologist I

Glaxosmithkline
Rockville, MD
GSK currently has an opening for an Associate Microbiologist in Rockville, MD. In this role, you'll be providing routine QC Microbiology laboratory, with the purpose of meeting daily routine requirements as well as achieving goals established by the manager.
**Key Responsibilities:**

+ Completes daily assigned routine tasks timely and accurately (may include collection and/or testing of GMP samples, reporting of data, assisting other Microbiologists, general lab housekeeping)

+ Paperwork completion, data entry, filing, etc.

+ Serves on team projects (i.e. qualifications, investigation) in the role of testing support and initiation of investigation

+ Responsible for completing laboratory housekeeping to ensure safety and compliance

+ Identifies areas for improvement or gaps in both safety and compliance (ZAPs/ZIPs)

+ Effectively communicates issues/hurdles to supervisor and/or manager

+ Supports GSK site initiatives and departmental goals

+ Job requires gowning into GMP manufacturing spaces to collect samples.

+ Requires holiday and weekend work

+ Supports investigations for EM and Clean Utilities

+ Must be able to lift 15-20 pounds

**_Why you?_**

**Basic Qualifications:**

_We are looking for professionals with these required skills to achieve our goals:_

+ BA/BS in Science field

+ Minimum of 1 year industrial experience in biopharmaceutical industry, such as Microbiology, Biology, or related field experience.

**Preferred Qualifications:**

**_If you have the following characteristics, it would be a plus:_**

+ Ability to work in team environment

+ Knowledge of lab equipment use and laboratory information systems

+ Excellent written and verbal communication skills.

**_Why GSK?_**

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.

*LI-GSK

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 (http://fortherecord.payments.us.gsk.com/content/hcppaymenttransparency/en/hcppayments/payments.html) site.

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .

Director Asset Lead Vaccines

Glaxosmithkline
Rockville, MD
Are you an experienced Global Clinical Operations Leader looking to make a broader impact in implementing all Vaccines Clinical Operations strategy plans?
If so, this **Director Asset Lead Vaccines** role is an ideal opportunity to explore.

This role can be based in Rockville, Maryland USA or in Mississauga, Ontario Canada.

**Job purpose:**

+ Representing all Clinical Operations functions at the program level and at the Vaccine Development Team (VDT), the Vaccine Commercial Team (VCT) and other project team interactions

+ Be accountable for the Operational Delivery Plan to execute the scientific strategy for an asset and associated studies, working in partnership with functional subject matter experts.

**Key Responsibilities:**

In this role you,

+ Are responsible for the execution and delivery of the Clinical Development Plan and Global Epidemiology Plans, including local studies

+ Are the Single Point of Contact for operational planning, feasibility and delivery of the assigned Project(s) and associated Development Plan(s) (e.g. Clinical Development Plan, Epidemiology Plans, etc.) from beginning to end

+ Support the development of project plans and coordinate expert input from clinical and non-clinical functions

+ Are responsible for the coordination and leadership of cross-functional team input into development plans, ensuring delivery of all studies included within the plans and working to resolve study issues that cannot be resolved at study level, by the Study Delivery Lead (SDL)

+ Build and provide robust estimates of timelines and costs, including resources

+ Manage execution of the approved development plans to time, budget and quality

To achieve this, you work closely with:

+ The Clinical and Epi Project Leads (CEPL), overall accountable for the Clinical Development Plan and for the Global EPI Plan

+ The Country Medical Director, for the local studies under your accountability

+ The Vaccine Development Team and/or the Vaccine Commercial Team

**_Why you?_**

**Basic Qualifications:**

We are looking for professionals with these required skills to achieve our goals:

+ Bachelor's level degree or advanced level degree in Pharmacy, Chemistry, Bioengineer, Biology, Biomedical Sciences or related field

+ 10+ years of experience in managing Clinical Research projects or equivalent

+ 10+ years of experience understanding project development, quality requirements and associated processes

+ Project management experience required

**Preferred Qualifications:**

If you have the following characteristics, it would be a plus:

+ You hold an MBA or a Project Management certification e.g. PMP

+ Project Management: you demonstrate experience in planning, coordinating, facilitating and executing projects in consideration of both project and business priorities. Expertise in setting, managing and tracking performance targets (including scope, budget, timeline and resource management including use of associated tools and Business Operations support where available)

+ Leadership: expertise in engaging, influencing and empowering others in order to accomplish individual, team and organizational objectives

+ Proven experience in effective people management in global and remote environment for mid-size multidisciplinary teams

**_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:_

+ Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk

+ Managing individual and team performance

+ Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution

+ Implementing change initiatives and leading change

+ Sustaining energy and well-being, building resilience in teams

+ Continuously looking for opportunities to learn, build skills and share learning both internally and externally

+ Developing people and building a talent pipeline

+ Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation

+ Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally

+ Budgeting and forecasting, commercial and financial acumen.

**_*This is a job description to aide in the job posting, but does not include all job evaluation details._**

**_*LI-GSK_**

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 (http://fortherecord.payments.us.gsk.com/content/hcppaymenttransparency/en/hcppayments/payments.html) site.

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .

Quality Processes Specialist

Glaxosmithkline
Rockville, MD
Are you energized by a quality assurance role that allows you to accelerate compliance in a state-of-the-art manufacturing environment? If so, this Quality Processes Specialist role could be an ideal opportunity to explore.

The purpose of the Quality Processes Specialist position is to provide support for activities that ensure the site manages and mitigates risk and maintains compliance. The Quality Processes Specialist 1 uses their skills and knowledge to perform the activities required to ensure senior staff have the data and information to ensure risks, compliance, and assessments can be performed effectively.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
+ Track and assess supplier-initiated changes and vendor complaints.

+ Manage change control associated with supplier changes.

+ Manage data collection forms for supplier related changes. Manage data collection forms for new and changed part numbers.

+ Support site Inspection Readiness initiatives including self-inspections, monitoring audits, third- party and regulatory inspections.

+ Support Data Integrity reviews at the site.

+ Trained as a site Qualified Internal Auditor and participate in at least 2 monitoring audits a year and working towards the competency to be a Lead Auditor.

+ Manage GMP documents by writing, reviewing, and/or managing document workflows

+ Provide metrics and Key Performance Indicators (KPIs) for management of risks and compliance

**_Why you?_**

**Basic Qualifications:**

_We are looking for professionals with these required skills to achieve our goals:_

+ BS Degree with a minimum of 2 years GXP experience

+ Experience working in a GMP regulated environment in a role directly related or supporting Quality or Manufacturing

**Preferred Qualifications:**

**_If you have the following characteristics, it would be a plus:_**

+ Good communication and interpersonal skills; good organization skills, attention to detail, ability to multitask, ability to work in a team environment, PC literate.

+ Strong knowledge in computerized systems such as Document Management, ERP, and/or CARISMA Plateau

+ Strong written and communication skills including group presentations and training

+ Ability to work in a cross-functional team as a team member

+ Attention to detail and good organizational skills

+ Strong written and communication skills including group presentations and training

+ Ability to work in a cross-functional team as a team member

+ Attention to detail and good organizational skills

**_Why GSK?_**

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.

***LI-GSK**

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 (http://fortherecord.payments.us.gsk.com/content/hcppaymenttransparency/en/hcppayments/payments.html) site.

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .

Associate Biochemist

Glaxosmithkline
Rockville, MD
As an Associate Biochemist in the QC-Chemistry team you will have the opportunity to be employed in a modern biological drug manufacturing site. As a member of our team you will be involved in analytical testing of biological medicines, using biochemistry methods as HPLC, CE, A280 and others in a GMP environment

_This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following..._

+ Perform routine testing duties including: testing samples for raw materials, product release and stability; comparability and non-GMP studies; critical reagent and assay qualifications, and assay validations.

+ Contributes to the completion of routine technical tasks and milestones associated with specific projects, such as executing studies and contributing to study reports and summaries for regulatory submissions. Works through obstacles; performs, and completes routine assignments according to written procedures in compliance with cGMP with general supervision.

+ Able to seek additional tasks or non-routine functions and accomplish them. Overcomes minor conflicts with priorities. Consults supervisor with major conflicts of priorities.

+ Proactive in attempting to learn the philosophy/ underlying principle behind relevant tests/ SOPs and their intended samples. Writes and reviews SOPs and participates in writing reports.
+ Infrequent inter-organizational and outside customer contacts on routine matters.

+ Able to effectively learn or train and teach procedures to other analysts. Communicates within group as well as with other groups within the department.

+ Work with manager to conduct laboratory investigations related to product testing

+ Trained as an L1 Auditor and participate in >25% of department's L1 Inspections.

**_Why you?_**

**Basic Qualifications:**

_We are looking for professionals with these required skills to achieve our goals:_

+ _Bachelor's Degree in a scientific discipline_

+ _2 or more years of pharmaceutical development and GMP_

+ _Proven experience working in teams to improve processes or resolve problems using organizational effectiveness tools._

**Preferred Qualifications:**

_If you have the following characteristics, it would be a plus:_

+ _Developing knowledge and application of the QMS (Quality Management System)._

+ _Knowledge of company products and quality impact as it relates to those products._

**_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.

**_*This is a job description to aide in the job posting, but does not include all job evaluation details._**

*LI-GSK

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 (http://fortherecord.payments.us.gsk.com/content/hcppaymenttransparency/en/hcppayments/payments.html) site.

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .

Manager, CMC

Glaxosmithkline
Rockville, MD
Are you energized by a challenging role in pharmaceutical R&D, where scientific demand is driving team growth? If so, this Manager, CMC would be a great opportunity to consider.
As a Manager, CMC, you will be responsible for the CMC regulatory activities of multiple projects

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

+ Drives the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements.

+ Provides regulatory advice and guidance to the Technical Development Team and/or Technical Life-Cycle Team (TLCT), Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel, and provides regulatory support to their partners in R&D, Quality Control, Manufacturing, QA and Supply.

+ Ensures adequate interaction and partnership with the Global Regulatory Lead's team in order to define proper regulatory CMC filing strategy.

+ Ensures adequate contribution during interactions with Worldwide regulatory authorities.

+ Ensures, in a continuous improvement mindset, regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.

+ May engage and lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment).

+ May mentor or train staff.

+ May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.

+ May deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).

**Why you?**

**Basic Qualifications:**

_We are looking for professionals with these required skills to achieve our goals:_

+ Bachelor's degree in Sciences or Medical Sciences

+ Experience managed multiple projects simultaneously.

+ Experience in drug development and manufacturing and supply processes and may have a specialized area of expertise.

+ Experience in CMC regulatory requirements.

+ Experience handling global CMC issues through continuous change and improvement

**Preferred Qualifications:**

_If you have the following characteristics, it would be a plus:_

+ Master's degree or above in Chemistry, pharmacy, biological or closely related science advanced degree.

+ Regulatory Affairs Certification (e.g. RAPS)

+ Experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of leadership in a matrix environment.

+ Sound knowledge of vaccines/biological products development, manufacturing and supply processes.

+ Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.

+ Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.

+ Identified as CMC Regulatory expert in a specific subject area.

+ Highly developed interpersonal, presentation and communication skills.

+ Proven experience in training staff within an organisation.

**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.

*LI-GSK

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 (http://fortherecord.payments.us.gsk.com/content/hcppaymenttransparency/en/hcppayments/payments.html) site.

We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .

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