3 Senior Manager Medical Writing jobs in Uxbridge
Senior Manager, Medical Writing
Uxbridge, London
Gilead Sciences, Inc.
Posted today
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional drug discovery, development and commercial product lifecycle management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world.
We have an exciting and unique opportunity for a senior level medical writer (Senior Manager, Medical Writing, Inflammation) to join our dynamic team. You will author a wide range of regulatory documents independently, including documents of high complexity. You will lead review and planning processes for multiple products or projects. You will represent Medical Writing on relevant product, project, and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other cross-functional initiatives. You will plan and have oversight for assigned medical writing deliverables and may serve as the filing lead for small to medium regulatory submissions. You will participate in process improvements, new standards, and updating document templates. You may coach, train, and provide guidance to less experienced Medical Writing colleagues. You may manage or supervise contractors to ensure the highest quality of medical writing and adherence to Gilead documents standards.
**EXAMPLE RESPONSIBILITIES:**
+ Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs all phases), investigator's brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.
+ May represent Medical Writing in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal presentation of data to achieve document intent.
+ Plans and oversees assigned medical writing deliverables with responsibilities including development and management of document timelines and resource planning for assigned projects.
+ May serve as the filing lead for small to medium regulatory submissions.
+ May serve as lead medical writer and department representative across development programs.
+ Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.
+ May also participate in other special projects and/or represent Medical Writing in other cross-functional initiatives.
+ Where applicable, oversees the work of external contractors supporting deliverables and other activities.
+ May coach, train, and provide guidance to less experienced Medical Writing colleagues.
+ Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Education & Experience**
BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry.
**Knowledge & Other Requirements**
+ Demonstrated ability to be a fast learner.
+ Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
+ Recognized as a SME in a broad range of regulatory documentation and a resource for specialist advice and guidance.
+ In-depth knowledge of relevant health authorities, including system, processes and requirements.
+ In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets, as evidenced by effectiveness and successes authoring a broad range of regulatory documentation.
+ Able to advise cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives.
+ Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
+ Ability to lead and influence programs, projects and/or initiatives.
+ Strong interpersonal skills and understanding of team dynamics.
+ Proven ability to work successfully in a team-oriented, highly matrixed environment.
+ When needed, ability to travel.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**POSITION OVERVIEW:**
Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional drug discovery, development and commercial product lifecycle management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world.
We have an exciting and unique opportunity for a senior level medical writer (Senior Manager, Medical Writing, Inflammation) to join our dynamic team. You will author a wide range of regulatory documents independently, including documents of high complexity. You will lead review and planning processes for multiple products or projects. You will represent Medical Writing on relevant product, project, and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other cross-functional initiatives. You will plan and have oversight for assigned medical writing deliverables and may serve as the filing lead for small to medium regulatory submissions. You will participate in process improvements, new standards, and updating document templates. You may coach, train, and provide guidance to less experienced Medical Writing colleagues. You may manage or supervise contractors to ensure the highest quality of medical writing and adherence to Gilead documents standards.
**EXAMPLE RESPONSIBILITIES:**
+ Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs all phases), investigator's brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.
+ May represent Medical Writing in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal presentation of data to achieve document intent.
+ Plans and oversees assigned medical writing deliverables with responsibilities including development and management of document timelines and resource planning for assigned projects.
+ May serve as the filing lead for small to medium regulatory submissions.
+ May serve as lead medical writer and department representative across development programs.
+ Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.
+ May also participate in other special projects and/or represent Medical Writing in other cross-functional initiatives.
+ Where applicable, oversees the work of external contractors supporting deliverables and other activities.
+ May coach, train, and provide guidance to less experienced Medical Writing colleagues.
+ Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
**Education & Experience**
BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry.
**Knowledge & Other Requirements**
+ Demonstrated ability to be a fast learner.
+ Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
+ Recognized as a SME in a broad range of regulatory documentation and a resource for specialist advice and guidance.
+ In-depth knowledge of relevant health authorities, including system, processes and requirements.
+ In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets, as evidenced by effectiveness and successes authoring a broad range of regulatory documentation.
+ Able to advise cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives.
+ Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
+ Ability to lead and influence programs, projects and/or initiatives.
+ Strong interpersonal skills and understanding of team dynamics.
+ Proven ability to work successfully in a team-oriented, highly matrixed environment.
+ When needed, ability to travel.
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This advertiser has chosen not to accept applicants from your region.
0
Manager, X-TA Regulatory Medical Writing
High Wycombe, South East
J&J Family of Companies
Posted today
Job Viewed
Job Description
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity?Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Manager, Regulatory Medical Writing** to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business.
The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). **While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.**
The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company
**Are you ready to join our team? Then please read further!**
**You will be responsible for:**
+ Preparing and finalizing all types of clinical documents independently within and across therapeutic areas (TAs).
+ Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
+ Lead and actively participate in setting functional tactics/strategy as needed.
+ Oversee the work of external contractors
+ Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
+ Guiding or training cross-functional team members on processes and best practices.
+ Potentially leading project-level/submission/indication writing teams.
+ If a lead writer for a program/compound (or submissions, indications, or disease areas): act as the primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
+ Actively participating in medical writing and cross-functional meetings.
+ Proactively provide recommendations for departmental process improvements.
+ Maintaining knowledge of industry, company, and regulatory guidelines.
+ Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
+ Interacting with senior cross-functional colleagues to strengthen coordination between departments.
+ Representing Medical Writing department in industry standards working groups if and as needed.
+ Complete all time reporting, training, and metrics database updates as required in relevant company systems.
+ If a people manager:
+ Manage a team of internal medical writers (direct reports).
+ Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions.
+ Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates.
+ Accountable for the quality of deliverables and for compliance of direct reports.
+ Participate in resource management and hiring decisions.
**Education and Experience Requirements:**
+ University/college degree required. Masters or PhD preferred.
+ At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
+ If a people manager, preferably up to 2 years of people management experience.
**Other Requirements:**
+ Experience of multiple therapeutic areas preferred.
+ Attention to detail.
+ Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
+ Expert project/time management skills.
+ Strong project/process leadership skills.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
+ Able to resolve complex problems independently.
+ Demonstrate learning agility.
+ Able to build and maintain solid and positive relationships with cross-functional team members.
+ Solid knowledge and application of regulatory guidance documents such as ICH requirements.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-020998
Netherlands, Belgium- Requisition Number: R-R-021535
United States - Requisition Number: R-R-021538
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $115,000 to $197,000 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
**Employees are eligible for the following time off benefits:**
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a **Manager, Regulatory Medical Writing** to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business.
The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). **While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.**
The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company
**Are you ready to join our team? Then please read further!**
**You will be responsible for:**
+ Preparing and finalizing all types of clinical documents independently within and across therapeutic areas (TAs).
+ Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
+ Lead and actively participate in setting functional tactics/strategy as needed.
+ Oversee the work of external contractors
+ Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
+ Guiding or training cross-functional team members on processes and best practices.
+ Potentially leading project-level/submission/indication writing teams.
+ If a lead writer for a program/compound (or submissions, indications, or disease areas): act as the primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
+ Actively participating in medical writing and cross-functional meetings.
+ Proactively provide recommendations for departmental process improvements.
+ Maintaining knowledge of industry, company, and regulatory guidelines.
+ Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
+ Interacting with senior cross-functional colleagues to strengthen coordination between departments.
+ Representing Medical Writing department in industry standards working groups if and as needed.
+ Complete all time reporting, training, and metrics database updates as required in relevant company systems.
+ If a people manager:
+ Manage a team of internal medical writers (direct reports).
+ Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions.
+ Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates.
+ Accountable for the quality of deliverables and for compliance of direct reports.
+ Participate in resource management and hiring decisions.
**Education and Experience Requirements:**
+ University/college degree required. Masters or PhD preferred.
+ At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
+ If a people manager, preferably up to 2 years of people management experience.
**Other Requirements:**
+ Experience of multiple therapeutic areas preferred.
+ Attention to detail.
+ Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
+ Expert project/time management skills.
+ Strong project/process leadership skills.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
+ Able to resolve complex problems independently.
+ Demonstrate learning agility.
+ Able to build and maintain solid and positive relationships with cross-functional team members.
+ Solid knowledge and application of regulatory guidance documents such as ICH requirements.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-020998
Netherlands, Belgium- Requisition Number: R-R-021535
United States - Requisition Number: R-R-021538
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $115,000 to $197,000 (USD).
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
**Employees are eligible for the following time off benefits:**
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
This advertiser has chosen not to accept applicants from your region.
1
Associate Director, X-TA Regulatory Medical Writing
High Wycombe, South East
J&J Family of Companies
Posted today
Job Viewed
Job Description
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity?Learn more at Function:**
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for an **Associate Director, Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing area.
This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to North America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. Remote work options may be considered on a case-by-case basis and if approved by the Company.
Are you ready to join our team? Then please read further!
**You will be responsible for:**
+ Leading compound/submission/indication/disease area writing teams independently.
+ May have additional major responsibility with supervision.
+ Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
+ Larger organizational responsibility (eg, manage a subset of TA).
+ Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
+ Leading program-level/submission writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks.
+ Guiding or training cross-functional team members on processes, best practices; coach or mentor more junior writers.
+ Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
+ Leading cross-functional/cross-TA, cross-J&J process improvement initiatives, or other large process working groups.
+ Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
+ If a lead writer for a program:
+ Primary point of contact and champion for Medical Writing activities for the clinical team.
+ Responsible for planning and leading the writing group for assigned program.
+ Able to function as a lead writer on any compound independently.
+ Leading discussions in Medical Writing and cross-functional meetings as appropriate.
+ Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.
+ Able to oversee the work of external contractors.
+ As a people manager:
+ Manage direct reports in Medical Writing.
+ Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates
+ Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
+ University/college degree in a scientific discipline is required. Masters or PhD preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
+ If a people manager, at least 2 years of people management experience.
+ Multiple therapeutic area experience preferred.
+ Strong attention to detail.
+ Strong oral and written communication skills. Fluent written and spoken English.
+ Expert project management skills, expert project/process improvement leadership.
+ Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
+ Ability to delegate responsibility to junior writers.
+ Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-020783
Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-021380
United States (East Coast)- Requisition Number: R-021383
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD)
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
**Employees are eligible for the following time off benefits:**
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
#LI-Hybrid
#LI-Remote
Medical Affairs Group
**Job Sub** **Function:**
Medical Writing
**Job Category:**
People Leader
**All Job Posting Locations:**
High Wycombe, Buckinghamshire, United Kingdom
**Job Description:**
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for an **Associate Director, Regulatory Medical Writing** within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing area.
This position is open globally and may be in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy), in addition to North America (eg, Spring House, PA, Raritan, NJ, or Titusville, NJ). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. Remote work options may be considered on a case-by-case basis and if approved by the Company.
Are you ready to join our team? Then please read further!
**You will be responsible for:**
+ Leading compound/submission/indication/disease area writing teams independently.
+ May have additional major responsibility with supervision.
+ Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
+ Larger organizational responsibility (eg, manage a subset of TA).
+ Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
+ Leading program-level/submission writing teams independently.
+ Directly leading or setting objectives for others on team projects and tasks.
+ Guiding or training cross-functional team members on processes, best practices; coach or mentor more junior writers.
+ Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
+ Leading cross-functional/cross-TA, cross-J&J process improvement initiatives, or other large process working groups.
+ Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
+ If a lead writer for a program:
+ Primary point of contact and champion for Medical Writing activities for the clinical team.
+ Responsible for planning and leading the writing group for assigned program.
+ Able to function as a lead writer on any compound independently.
+ Leading discussions in Medical Writing and cross-functional meetings as appropriate.
+ Interacting with senior cross-functional colleagues and external partners to strengthen coordination between departments.
+ Able to oversee the work of external contractors.
+ As a people manager:
+ Manage direct reports in Medical Writing.
+ Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
+ Ensures direct report's adherence to established policies, procedural documents, and templates
+ Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.
**Qualifications /Requirements:**
+ University/college degree in a scientific discipline is required. Masters or PhD preferred.
+ At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required!
+ If a people manager, at least 2 years of people management experience.
+ Multiple therapeutic area experience preferred.
+ Strong attention to detail.
+ Strong oral and written communication skills. Fluent written and spoken English.
+ Expert project management skills, expert project/process improvement leadership.
+ Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
+ Ability to delegate responsibility to junior writers.
+ Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
+ Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United Kingdom - Requisition Number: R-020783
Europe (BE/FR/DE/IRE/IT/NL/ES)- Requisition Number: R-021380
United States (East Coast)- Requisition Number: R-021383
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
**For United States applicants:**
The anticipated base pay range for this position is $137,000 to $235,750 (USD)
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
**Employees are eligible for the following time off benefits:**
- Vacation - up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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