Bangalore
2 years ago
27 Applied
JOB ID:44004
Job details
Job Type
Full Time
Functional Area
Content Writer/Editor/Journalist
Industry
Pharma/Biotech/Clinical Research
Education
Not Specified
Experience Required
2 - 5 Yrs
Key Skills Required
content writing
Other Skills Required
Languages
English
Job Description
Associate Scientific writer
Develop content for various deliverables meeting quality requirements as per client satisfaction metrics, with active guidance from the manager
Responsible for the life cycle management of the label/IFUs right from signal assessment and update to dossier dispatch and health authority query resolution
· Effectively collaborate with relevant external stakeholders in obtaining necessary supporting documents and expert opinion for labeling updates or query resolution following health authority submissions
· Convene and lead labeling working group meetings to facilitate review and endorsement of global/local labeling proposals or health authority responses.
· Presentation of corporate labeling documents/local labels/IFUs through the governance process and have it approved in a timely manner
Comparison of risks across IFUs and creation of Risk Master List (RML) in a corporate database
· Liaise with regional or local affiliates regarding queries including health authority... See More
Develop content for various deliverables meeting quality requirements as per client satisfaction metrics, with active guidance from the manager
Responsible for the life cycle management of the label/IFUs right from signal assessment and update to dossier dispatch and health authority query resolution
· Effectively collaborate with relevant external stakeholders in obtaining necessary supporting documents and expert opinion for labeling updates or query resolution following health authority submissions
· Convene and lead labeling working group meetings to facilitate review and endorsement of global/local labeling proposals or health authority responses.
· Presentation of corporate labeling documents/local labels/IFUs through the governance process and have it approved in a timely manner
Comparison of risks across IFUs and creation of Risk Master List (RML) in a corporate database
· Liaise with regional or local affiliates regarding queries including health authority... See More
Associate Scientific writer
Develop content for various deliverables meeting quality requirements as per client satisfaction metrics, with active guidance from the manager
Responsible for the life cycle management of the label/IFUs right from signal assessment and update to dossier dispatch and health authority query resolution
· Effectively collaborate with relevant external stakeholders in obtaining necessary supporting documents and expert opinion for labeling updates or query resolution following health authority submissions
· Convene and lead labeling working group meetings to facilitate review and endorsement of global/local labeling proposals or health authority responses.
· Presentation of corporate labeling documents/local labels/IFUs through the governance process and have it approved in a timely manner
Comparison of risks across IFUs and creation of Risk Master List (RML) in a corporate database
· Liaise with regional or local affiliates regarding queries including health authority questions and collaborate with the global team to address the questions
· Be compliant to quality and both internal and external timelines for all regulatory submissions.
· Providing labeling contribution to PBRER, ACO, annual report, and other regulatory submissions document.
Conduct quality checks to ensure the accuracy and consistency of data included in documents
· Operational support to handle, distribute or manage incoming work and support Hub Labeling Managers in processing labeling projects
· Responsible for maintenance and approval of corporate/local labels while ensuring consistency with applicable core labeling documents and Client standards and SOPs and specific country regulations.
· Adhering to compliance procedures and internal/operational risk controls in accordance with all applicable regulatory standards, requirements and policies.
Communicate and interact effectively within and across all key stakeholders and within internal team as appropriate.
· Demonstrate good technical competence of understanding of relationship with Business Partners.
Follow the best practices while executing projects in the team with regard to processes, communication documentation and technical requirements like language, grammar, style, content search, summarising, data conflicts and referencing
· Follow the best practices while executing projects in the team with regard to processes, communication documentation and technical requirements like language, grammar, style, content search, summarising, data conflicts and referencing
Analyse challenges/limitations in content development and provide logical, unbiased and rational recommendations for modifying quality standards or introducing newer ones
Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective
Desired Profile
1.Minimum 2 to 3 years of experience in pharmaceutical companies in any of the following functions—labeling/clinical research/regulatory affairs or in medical writing/developing/publishing medical content.
OR
A minimum of 2 to 3 years of experience in any clinical practice
2.Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
3.Strong flair and passion for writing.
4.Strong written and verbal communication/presentation skills.
5.Passion for networking.
6.Being up-to-date with the latest technical/scientific developments and relating them to various projects.
Soft Skills
a. Client focus
b. Result orientation
c. Communicating with Impact
d. Team player
e. Process oriented See Less
Develop content for various deliverables meeting quality requirements as per client satisfaction metrics, with active guidance from the manager
Responsible for the life cycle management of the label/IFUs right from signal assessment and update to dossier dispatch and health authority query resolution
· Effectively collaborate with relevant external stakeholders in obtaining necessary supporting documents and expert opinion for labeling updates or query resolution following health authority submissions
· Convene and lead labeling working group meetings to facilitate review and endorsement of global/local labeling proposals or health authority responses.
· Presentation of corporate labeling documents/local labels/IFUs through the governance process and have it approved in a timely manner
Comparison of risks across IFUs and creation of Risk Master List (RML) in a corporate database
· Liaise with regional or local affiliates regarding queries including health authority questions and collaborate with the global team to address the questions
· Be compliant to quality and both internal and external timelines for all regulatory submissions.
· Providing labeling contribution to PBRER, ACO, annual report, and other regulatory submissions document.
Conduct quality checks to ensure the accuracy and consistency of data included in documents
· Operational support to handle, distribute or manage incoming work and support Hub Labeling Managers in processing labeling projects
· Responsible for maintenance and approval of corporate/local labels while ensuring consistency with applicable core labeling documents and Client standards and SOPs and specific country regulations.
· Adhering to compliance procedures and internal/operational risk controls in accordance with all applicable regulatory standards, requirements and policies.
Communicate and interact effectively within and across all key stakeholders and within internal team as appropriate.
· Demonstrate good technical competence of understanding of relationship with Business Partners.
Follow the best practices while executing projects in the team with regard to processes, communication documentation and technical requirements like language, grammar, style, content search, summarising, data conflicts and referencing
· Follow the best practices while executing projects in the team with regard to processes, communication documentation and technical requirements like language, grammar, style, content search, summarising, data conflicts and referencing
Analyse challenges/limitations in content development and provide logical, unbiased and rational recommendations for modifying quality standards or introducing newer ones
Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective
Desired Profile
1.Minimum 2 to 3 years of experience in pharmaceutical companies in any of the following functions—labeling/clinical research/regulatory affairs or in medical writing/developing/publishing medical content.
OR
A minimum of 2 to 3 years of experience in any clinical practice
2.Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
3.Strong flair and passion for writing.
4.Strong written and verbal communication/presentation skills.
5.Passion for networking.
6.Being up-to-date with the latest technical/scientific developments and relating them to various projects.
Soft Skills
a. Client focus
b. Result orientation
c. Communicating with Impact
d. Team player
e. Process oriented See Less
Additional Information
Cab Facility ProvidedAbout Company
Indegene helps global healthcare organizations address complex challenges by seamlessly integrating analytics, technology, operations and medical expertise. Indegene helps clients drive outcomes, revenue and productivity improvements by making giant leaps in digital transformation, customer engagement, health reform, healthcare cost reduction, and health outcomes improvement.
Indegene has a global footprint with offices in North America, Europe, China and India.
Recommended Companies
Recommended Events
