Manager - Medical Writing
Manager - Medical Writing
Posted on :
20-01-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: Manager Medical Writing
Job Location: Bengaluru East Bengaluru Karnataka 562129 India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals people the planet and our enterprise.
At Elanco we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation creativity and overall business success. Here you’ll be part of a company that values and champions new ways of thinking work with dynamic individuals and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Position Title: Manager Medical Writing
Supervisor Title: Team Leader – Scientific Writing and Document Publishing
Job Function: Medical Writing
Position Type: Full Time
Location: Bangalore Karnataka India
Position Description:
Responsible for the preparation of regulatory and scientific documents including but not limited to final study reports (FSRs) in accordance with VICH GL9 OECD Principles EMA and FDA or any other applicable regulatory requirements. Additionally draft scientific communications abstracts posters slide sets manuscripts for publication literature searches etc. ensuring comprehensive high quality scientifically accurate and consistent information in consultation with regulatory and Global R&D Sites and Project Teams.
Functions Duties Tasks:
As a global leader in animal health we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals people the planet and our enterprise.
At Elanco we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation creativity and overall business success. Here you’ll be part of a company that values and champions new ways of thinking work with dynamic individuals and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Position Title: Manager Medical Writing
Supervisor Title: Team Leader – Scientific Writing and Document Publishing
Job Function: Medical Writing
Position Type: Full Time
Location: Bangalore Karnataka India
Position Description:
Responsible for the preparation of regulatory and scientific documents including but not limited to final study reports (FSRs) in accordance with VICH GL9 OECD Principles EMA and FDA or any other applicable regulatory requirements. Additionally draft scientific communications abstracts posters slide sets manuscripts for publication literature searches etc. ensuring comprehensive high quality scientifically accurate and consistent information in consultation with regulatory and Global R&D Sites and Project Teams.
Functions Duties Tasks:
- Interprets safety efficacy and pharmacokinetic study data sets.
- Prepares final study reports PK reports summary reports and other reports as needed.
- Prepares literature searches abstracts posters slide sets manuscripts including review articles.
- Performs proof reading and quality control (QC) review of deliverables to meet customer expectations.
- Obtains feedback from customers and implements customer management requirements.
- Manages multiple projects at any given time along with tracking project milestones.
- Complies with and supports group's project management tool standards policies and initiatives.
- Follows Elanco specifications for documentation specifically good documentation practices.
- Works closely in consultation with Regulatory R&D sites and global project teams.
- Serves as medical writing lead for identified projects/programs and proactively plan and identify document preparation strategies
- Maintains records for all assigned projects in accesscontrolled folders.
- Maintains audit SOP and training compliance.
- Masters or Ph.D in veterinary medicine pharmacology biochemistry microbiology biotechnology or PharmD or any life sciences.
- Three to five years of proven medical writing experience in an R&D operational group (e.g. conducting research studies involving study protocol preparation).
- Should have written clinical study reports or authored and published manuscripts in reputed international journals.
- Should have worked with global stakeholders across multiple functions.
- Indepth knowledge of drug development guidelines with sound understanding of operational Regulatory and R&D principles.
- Excellent oral and written communication skills with ability to communicate logically and technically.
- Prior experience in writing for animal health will be an added advantage.
- Organizational planning skills project management skills and commitment to quality.
- High competency in Microsoft Office applications with experience with other document authoring tools.
- Travel percentage up to 10%.
- You will be part of the Global Development Operations Team.
- You will work with groups in the USA Australia and EU region.
- You will manage Elanco operational requirements locally and ensure implementation of Policies and Procedures.
- You will be required to indirectly manage stakeholders that are part of global scientific teams.
- You will be part of project teams as required.
/jobs/view/059e5434df6e56a88bba9dd013b58c71
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
