19 Freelance Writing jobs in the United Kingdom

Grant Writing Associate

Reading, South East Mondelez International

Posted 15 days ago

Job Viewed

Tap Again To Close

Job Description

**Job Description**
**Are You Ready to Make an Impact at RSSL?**
**Join Our Mission to Transform Lives Through Science, Innovation and Collaboration**
At Reading Scientific Services Ltd (RSSL), we lead the way in scientific analysis, research, consultancy, and training. We provide services to the food, pharmaceutical, and consumer goods industries, as well as our parent company, Mondelez International. RSSL is dedicated to delivering world-class scientific solutions and outstanding customer service.
Recognised for our excellence, we were awarded CRO of the Year at the 2023 OBN Awards, adding to our previous accolades Employer of the Year, Enlightened Employer and Women in Business.
If you are passionate about driving innovation and making a real impact, RSSL is the place for you!
Purpose:
A 6-month fixed-term contract to help the team in RSSL with applying and delivering government-funded projects. We are looking for someone with previous experience in this environment; with previous experience in writing grant applications, or managing government-funded projects.
**Role Responsibilities:**
+ Lead & contribute to project activities, such as meetings, preparation of communications i.e. newsletters, surveys, emails and network materials
+ Co-ordinate & contribute to workshops, events & meetings.
+ Conduct activities to support with building the network community
+ Contribute to project administration tasks e.g. collating slides for project review meetings, chasing actions, collating metrics
+ Contribute to the identification of new grants competitions, scope projects and support with bid writing
**Skills needed:**
+ Very organised person with attention to detail skills - to ensure specifics are delivered
+ Meeting & event management experience
+ Team player but can work on own initiative
+ Experience in IUK grant writing - preferred
+ Knowledge of food industry - preferred
**More about this role**
In return for your commitment, drive and enthusiasm, we offer an attractive benefits package within a highly successful international business that offers financial rewards and resources, including:
+ Opportunities to learn and develop
+ Performance Related Bonus scheme
+ Contributory pension (between 8% to 11% employer contribution)
+ Life assurance
+ 27 days holiday allowance (possibility to buy 5 extra days) + bank holidays
+ Employee Assistance Programme (EAP)
+ A flexible benefits programme (Gym discounts, private health insurance, restaurant discounts, etc).
**Business Unit Summary**
Reading Scientific Services Ltd (RSSL) is a cutting-edge contract research organisation (CRO), providing research, analysis and consultancy to the food, consumer goods and life science sectors. Whether we are creating new products, validating medicines or solving investigations, we take pride in being a leader in our field, serving clients from across 70 countries. Enriched by our parent company, Mondelez International, our team are committed to transforming lives through science, innovation and collaboration.
**Curious about us and want to learn more?**
**Please explore** : Website ( YouTube LinkedIn ( Glassdoor
RSSL is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.
#RSSL
**Job Type**
Temporary (Fixed Term)
Analytical Science
Science & Engineering
At Mondelez International, our purpose is to empower people to snack right through offering the right snack, for the right moment, made the right way. That means delivering a broader range of delicious, high-quality snacks that nourish life's moments, made with sustainable ingredients and packaging that consumers can feel good about.
We have a rich portfolio of strong brands - both global and local. Including many household names such as Oreo, belVita and LU biscuits; Cadbury Dairy Milk, Milka and Toblerone chocolate; Sour Patch Kids candy and Trident gum. We are proud to hold the number 1 position globally in biscuits, chocolate and candy as well as the No. 2 position in gum
Our 80,000 Makers and Bakers are located in our operations in more than 80 countries and are working to sell our products in over 150 countries around the world. They are energized for growth and critical to us living our purpose and values. We are a diverse community that can make things happen, and happen fast.
Join us and Make It An Opportunity!
Mondelez Global LLC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, sexual orientation, gender identity, gender expression, genetic information, or any other characteristic protected by law. Applicants who require accommodation to participate in the job application process may contact for assistance.
This advertiser has chosen not to accept applicants from your region.

Manager Medical Writing

Meet Life Sciences

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

We are seeking an experienced Medical Writing Manager / Lead to oversee the planning, coordination, and delivery of key regulatory and scientific documents. The role involves collaboration with cross-functional teams, management of multiple projects, and a focus on delivering high-quality, compliant documentation.


Main Responsibilities

  • Oversee the end-to-end management of medical writing projects, including planning, timeline management, stakeholder coordination, and delivery of final documents.
  • Lead the development of a range of documents, including protocol outlines, informed consent forms, clinical study reports, sections of Module 2 of the eCTD, patient-facing materials, lay summaries, registry content, publications, posters, and abstracts.
  • Ensure all content is scientifically accurate, clear, and consistent, meeting regulatory and internal quality standards.
  • Coordinate with internal teams (clinical, regulatory, biostatistics, data management, patient engagement, project management) and external partners (CROs, KOLs, patient advocacy groups) to gather input and ensure alignment on objectives.
  • Conduct quality control checks for accuracy, grammar, formatting, and template compliance across all documents.
  • Ensure all documentation complies with applicable regulatory guidelines and company SOPs, and support submission readiness.
  • Contribute to process improvement initiatives, including the implementation of AI tools and digital repositories to enhance document development efficiency.
  • Maintain accurate records of timelines, milestones, and deliverables, providing regular progress updates to stakeholders.
  • Support training and mentoring of junior writers, promoting collaboration and continuous learning within the team.

Requirements

  • 5–8 years of medical writing and project management experience in the pharmaceutical, biotech, or related industry.
  • Proven experience in a senior or principal medical writing role.
  • Bachelor's degree in life sciences, pharmacy, or a related field; an advanced degree (e.g. MSc, PhD) is preferred.
  • Fluency in English (spoken and written).
  • Strong knowledge of scientific and medical terminology, regulatory guidelines, and clinical trial processes.
  • Excellent project management, organizational, and communication skills.
  • Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.
  • Experience mentoring junior team members is a plus.
This advertiser has chosen not to accept applicants from your region.

Director of Regulatory Writing

Complete Regulatory | An IPG Health Company

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Who are we?

Complete Regulatory is part of IPG Health Medical Communications, who is home to the world’s most celebrated and awarded Med Comms agencies. We are 800 experts obsessed with combining science, creativity, and technology to create exceptional medical communications solutions for our clients.


What do we do?

At Complete Regulatory,, we provide class-leading writing support and consultancy services to the pharmaceutical industry, producing a wide range of high-quality clinical documentation, including clinical study reports, protocols, clinical summaries, clinical overviews, regulatory responses and other supporting documents, across a variety of therapy areas.


The role

We are looking for experienced Directors of Regulatory Writing with previous experience as a regulatory writer within the pharmaceutical industry and/or a medical writing agency to join our team and help us to build on our continuing success. You will use your thorough knowledge of regulatory documents and development of submission documentation to lead complex submissions and guide other team members.


Our clients value our services very highly and in this role you will work as a trusted partner with various companies, to provide high-level leadership and support on a range of project types and therapy areas. You will help to maintain our excellent client relationships, which will allow you to consult with the client and demonstrate your high-level strategic thinking, based on extensive past experience, to ensure effective medical writing for regulatory authorities.


What will you get in return?

This position will benefit anyone looking to build on their experience in regulatory writing, while working within a highly specialised, supportive and reputable team. In addition, you will become part of a larger organisation, which offers a range of world-class services and a flexible organisational structure.


As well as a fresh challenge in your career, long term career choices and development, you will be rewarded with:


· Flexible Time Off – uncapped paid time off

· Retail and gym discounts

· Great training and development

· Life assurance

· Pension

· Employee assistance programme

· Private healthcare

· Headspace and MYNDUP - a mental health wellness programme

· Cycle to work scheme

· Long Service Award

· Season Ticket Loan

· Flexible working


To Apply or Contact Us

Apply by clicking the link below.


IPG Health Medical Communications is home to the world’s most celebrated and awarded med comms agencies, united by a healthy obsession with creating exceptional medical communications for our clients. Our people are the beating heart of our organisation, and through the positive culture we champion, our teams create communications that not only have a positive impact for our clients, but also impact on the world around us.


We celebrate diversity and encourage applicants from all whatever their background and/or disability. We want you to have every opportunity to shine and show us your talents, so please reach out and let us know if there are any reasonable adjustments we can make to ensure our assessment process works for you.

This advertiser has chosen not to accept applicants from your region.

Regulatory Medical Writing Lead

Cpl Life Sciences

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Job Role: Regulatory Medical Writing Lead

Job Type: Full-time, permanent.

Job Location: UK, Remote – Travel 1x a quarter to the office in Surrey.

Remuneration: £75,000 - £99,000 plus car allowance and bonus.


An opportunity to join a growing specialty pharmaceutical company that focuses on developing innovative treatments for hard-to-treat diseases, with key areas including immuno-oncology, gene therapy, mitochondrial biology, blindness and regeneration, and targeted protein degradation.


Acts as a Global Medical Writing Lead, generally in mid- to late-stage development global project teams. The individual provides leadership with respect to all program documents and may act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs.


The individual independently analyzes proposed program, study, and related documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency. The individual reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history; ensures a consistent pattern of successful completion of assigned responsibilities within a program resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements; and provides intellectual leadership and contributes document knowledge and expertise to the global project team.


Responsibilities:

  • Acts as a primary lead for all assigned programs (generally mid- to late-stage development).
  • As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team.
  • May act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs.
  • Reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history, ensuring a consistent pattern of successful completion of assigned responsibilities resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements.
  • For all documents within a program, independently implements adjustments in specific document content within framework of provided templates in order to fit the needs of specific document/core team requirements.
  • Participates in standards and processes initiatives/activities and other departmental project activities (up to a total of 15% of time).
  • May participate in a multidiscipline productivity or process initiative.
  • Supports Line Management in the improvement of departmental performance and outsourcing alliances through analysis and evaluation of metrics and performance data.


Required Qualifications:

  • BA/BS degree or equivalent, 10+ years relevant experience. Preferred: PhD/Pharm D or MS/MA/MPH with at least 10 years as a writing professional in pharmaceutical industry, with 2-5 years' experience in managing/supervising activities associated with the creation of regulated documents in the pharmaceutical industry.
  • Technical expert on all document types produced by medical writing.
  • Demonstrated and substantial experience in leading/managing the creation of IND/IMPD and NDA/MAA components, briefing documents, responses to regulatory authorities. Preferred experience in preparing for advisory committees.
  • Strong communication and leadership skills; strategic thinker.


Please note this role is a senior role within the business so you MUST have extensive experience in RA medical writing and have excellent communication skills.


The role DOES NOT offer job sponsorship so you must hold the full right to work in the UK and be based in the United Kingdom.


For more information please reach out to me at

This advertiser has chosen not to accept applicants from your region.

Senior Medical Writer (Regulatory Writing)

Reading, South East IQVIA

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

**Job Overview**
Acts as Lead Medical Writer on most types of writing projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments. Provides written and verbal feedback to junior staff, and to customers when appropriate. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.
**Essential Functions**
- Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
- Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
- Lead meetings on more challenging topics independently.
- May present on standard Medical Writing processes at full-service bid defense meetings.
- Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others. May develop and deliver training to the global team on a topic he/she has specific expertise in. May input into and deliver presentations on Medical Writing to other IQVIA groups.
- May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.
- Complete project finance activities, including monitoring and forecasting budgeted hours.
- Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.
- May take on a small customer lead role or assist an established partnership lead in their role.
- May represent region or site on a Medical Writing initiative or cross-functional initiative.
- Facilitates and brainstorms the identification of new ideas. May represent Medical Writing at a general capabilities audit.
**Qualifications, Experience and Skills**
- Bachelor's Degree n life sciences related discipline or related field required
- Master's Degree in life sciences related discipline or related field preferred
- Ph.D. in life sciences related discipline or related field preferred
- Typically requires at least 5 years of highly relevant experience in regulatory writing and related competency levels.
- In-depth knowledge of the structural and content requirements of clinical study reports (CSR), protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
- Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
- Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
- Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.
- In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
- Excellent written and oral communication skills including grammatical/technical writing skills.
- Excellent attention to detail and accuracy.
- Confident and effective communication and negotiation skills with customers and project managers.
- Able to deliver difficult messages in constructive manner.
- Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
- Demonstrated abilities in collaboration with others and independent thought.
- Demonstrates confidence and maturity in most routine medical writing situations.
- Demonstrates good judgement in requesting input from senior staff.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
- Ability to effectively manage multiple tasks and projects.
- Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.
- Must be computer literate.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.

Medical Writing Vacancies (Multiple Levels)

Carys Mills Consulting

Posted today

Job Viewed

Tap Again To Close

Job Description

We have writing vacancies across multiple levels;

  • Medical Writer
  • Senior Medical Writer
  • Principal Medical Writer
  • Copywriter/Senior Copywriter


Each role is with a fantastic healthcare communications agency, with locations across the UK (offering both remote and hybrid work)


PLEASE NOTE: These roles are available for UK BASED CANDIDATES ONLY. If you are outside of the UK please DO NOT APPLY.


Perks and Benefits:

  • HYBRID AND REMOTE ROLES
  • COLLABORATIVE, INNOVATIVE TEAMS
  • EXCEPTIONAL BENEFITS ABOVE INDUSTRY STANDARD


Candidates must have:

  • Experience in a medical writing role as part of a healthcare comms agency
  • Minimum BSc in life sciences (PhD advantageous)
  • Experience working across a variety of materials, including publications (experience in Neurology/Oncology/Rare diseases/HIV advantageous)
This advertiser has chosen not to accept applicants from your region.

Senior Manager, Regulatory Medical Writing

Cpl Life Sciences

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Job Role: Senior Manager, Regulatory Medical Writing

Job Type: Full-time, permanent.

Job Location: UK, Remote – Travel 1x a quarter to the office in Surrey.

Remuneration: £56,000 - £75,000 plus car allowance and bonus.


An opportunity to join a growing specialty pharmaceutical company that focuses on developing innovative treatments for hard-to-treat diseases, with key areas including immuno-oncology, gene therapy, mitochondrial biology, blindness and regeneration, and targeted protein degradation.


Acts as a Global Medical Writing Lead, generally in mid- to late-stage development global project teams. The individual provides leadership with respect to all program documents and may act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs.


The individual independently analyzes proposed program, study, and related documents for their ability to deliver the information required by the target audience (e.g., regulatory authority) with accuracy and consistency. The individual reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history; ensures a consistent pattern of successful completion of assigned responsibilities within a program resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements; and provides intellectual leadership and contributes document knowledge and expertise to the global project team.


Responsibilities:

  • Acts as a primary lead for all assigned programs (generally mid- to late-stage development).
  • As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team.
  • May act as the departmental expert on IND/IMPD dossier components, briefing documents, and responses to regulatory authorities across programs.
  • Reviews documents within a therapeutic area with respect to consistency with the team/corporate established strategy and document history, ensuring a consistent pattern of successful completion of assigned responsibilities resulting in the production of high-quality documents that meet corporate needs and global regulatory requirements.
  • For all documents within a program, independently implements adjustments in specific document content within framework of provided templates in order to fit the needs of specific document/core team requirements.
  • Participates in standards and processes initiatives/activities and other departmental project activities (up to a total of 15% of time).
  • May participate in a multidiscipline productivity or process initiative.
  • Supports Line Management in the improvement of departmental performance and outsourcing alliances through analysis and evaluation of metrics and performance data.


Required Qualifications:

  • BA/BS degree or equivalent, 10+ years relevant experience. Preferred: PhD/Pharm D or MS/MA/MPH with at least 10 years as a writing professional in the pharmaceutical industry, with 2-5 years' experience in managing/supervising activities associated with the creation of regulated documents in the pharmaceutical industry.
  • Technical expert on all document types produced by medical writing.
  • Demonstrated and substantial experience in leading/managing the creation of IND/IMPD and NDA/MAA components, briefing documents, and responses to regulatory authorities. Preferred experience in preparing for advisory committees.
  • Strong communication and leadership skills; strategic thinker.


Please note this role is a senior role within the business, so you MUST have extensive experience in RA medical writing and have excellent communication skills.


The role DOES NOT offer job sponsorship, so you must hold the full right to work in the UK and be based in the United Kingdom.


For more information please reach out to me at

This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Freelance writing Jobs in United Kingdom !

Manager,X-TA Regulatory Medical Writing

High Wycombe, South East J&J Family of Companies

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough 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.u202fLearn more at


**Job 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


We 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 reportu2019s 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 crossu2010functional 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 corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s 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 Companyu2019s 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:


The 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.

Manager, X-TA Regulatory Medical Writing

High Wycombe, South East J&J Family of Companies

Posted 10 days ago

Job Viewed

Tap Again To Close

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
This advertiser has chosen not to accept applicants from your region.

Associate Director,X-TA Regulatory Medical Writing

High Wycombe, South East J&J Family of Companies

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

At Johnson & Johnson,u202fwe believe health is everything. Our strength in healthcare innovation empowers us to build au202fworld where complex diseases are prevented, treated, and cured,u202fwhere treatments are smarter and less invasive, andu202fsolutions are personal.u202fThrough 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.u202fLearn more at


**Job 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


We 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 crossu2010functional 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 crossu2010functional/crossu2010TA, crossu2010J&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 crossu2010functional meetings as appropriate.
Interacting with senior crossu2010functional 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 reportu2019s 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 corporationu2019s performance over a calendar/ performance year. Bonuses are awarded at the Companyu2019s 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 Companyu2019s 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:


The 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.
 

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Freelance Writing Jobs