DAYANA JOSE
Chennai
Summary
Efficient medical writing professional with experience in preparing accurate technical documents in the field of clinical research. An expert at delivering high-quality work within tight deadlines and someone who collaborates with cross-functional teams for accuracy and clarity of technical content.
Overview
14
14
years of professional experience
6
6
years of post-secondary education
1
1
Certification
1
1
Language
Work History
Senior Drug Safety Associate (Scientific Writing)
Accenture Operations
Chennai
02.2021 - Current
- Author CSRs.
- Author Safety narratives.
- Author IB updates and review aid tables.
- End to end QC of CSRs, clinical study protocols, IBs, and RMPs.
- Followed company policies and editorial guidelines (e.g., AMA style guide and Client Specific Templates) to craft thorough, well-written content.
- Proved successful in working within tight deadlines and a fast-paced environment.
- Have expert proficiency with styles for various scientific document types and with client templates, toolbars, and style guides.
- Took initiative to suggest and implement medical writing process improvements, and followed through to completion.
- Edited and proofread clinical trails documents for accuracy and consistency.
- Skilled at working independently and collaboratively in team environment.
- Applied effective time management techniques to meet tight deadlines.
- Strengthened communication skills through regular interactions with others.
- Resolved problems, improved operations and provided exceptional service.
- Negotiated on behalf of medical writing to align resources, timelines and expectations.
- Collaborated with clinicians, clinical scientists and biostatisticians to interpret study results and accurately reflect in relevant documents.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
Assistant Professor
KMP College of Pharmacy
Ernakulam
04.2019 - 12.2020
- Evaluated and supervised student activities and performance levels to provide reports on academic progress.
- Collaborated with colleagues on curriculum revision, evaluation of course syllabi and lesson plans for pharmacy curriculum.
- Contributed to campus activities to promote positive college image.
- Proctored exams and provided remediation for learning improvement goals.
- Revised course objectives, course materials, instructional and assessment strategies for pharmacology and pharmacy practice courses.
- Built strong rapport with students through class discussions and academic advisement.
- Mentored students and communicated internship and employment opportunities.
- Mentored students and communicated internship and employment opportunities
Documentation Assistant (Part-Time)
Naerum Apotek
Copenhagen
01.2017 - 11.2017
- Identified audit parameters to comply with quality standards.
- Collaborated with quality assurance team to comply with regulatory requirements.
- Assisted compliance team to gather necessary documentation.
- Translated complex technical information into intuitive clear format.
QC Analyst I (Medical Writing)
MMSH Clinical Research Pvt. Ltd
Bangalore
11.2015 - 11.2016
- QC of CSRs, Protocols, IBs, RMPs, Clinical Summary, Clinical Overview
- Authored different sections of CSRs
- Authored safety narratives
- Authored layman's summary
- Authored Clinical Trials Disclosures
- Responsible for planning and on-time delivery of project delivery
- Interacted with cross-functional team members to ensure completion of all timelines and studies
- Ensured compliance with company quality processes throughout project lifecycle
- Provided creative solutions to meet tight regulatory timelines and high level of technical support
- Trained via self-study and self-practice and explores advanced topics related to medical writing and/or drug development
- Critically reviewed and addressed client comments and provided value-added suggestions
Pharmacist
Radha Medicals and Distributors Pvt. Ltd
Mangalore
02.2014 - 04.2015
- Educated patients about possible drug interactions and gave special administration instructions.
- Assisted other pharmacy staff with drug inventory, purchasing and receiving.
- Hand counted controlled medications, measured liquids and reconstituted antibiotics.
- Educated patients on proper medication use.
- Counseled patients regarding proper intake of medications.
- Dispensed and verified patient prescription orders, conducting necessary utilization reviews.
QC Analyst
Dyna Vetcare
Kozhikode
09.2010 - 11.2011
- Developed and maintained quality assurance procedure documentation.
- Participated in departmental meetings to establish short- and long-term strategy.
- Edited, and proof read internal documents to improve clarity.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Analyzed quality and performance data to support operational decision-making.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
Education
Master of Pharmacy - Pharmacology
Shree Devi College Of Pharmacy, Mangalore
Mangalore 12.2011 - 12.2013
Bachelor of Pharmacy - Pharmacy
Kalasalingam College of Pharmacy
Virudhunagar, TN 09.2006 - 08.2010
Skills
CSRs, Narratives, Disclosures, IB updates, layman's summary, SOP writing
Content Review/QC of scientific documents including protocols, CSRs, IBs, RMPs, Briefing Documents, Clinical Overview, Clinical Summary, and Informed Consent Form
Expert in AMA style guide
Analytical and problem-solving skills
Excellent interpersonal skills
Excellent verbal / written communication skills
Excellent organizational and prioritization skills
Client focused approach to work
Process Documentation
Experience in working on CARA and Veeva Vault
Certification
Advanced Diploma in Clinical Research and Regulatory Writing - May 2015-Oct 2015 ICBio Clinical Research Pvt Ltd, Bangalore
Accomplishments
- Won spot award by the tower lead multiple times
- Supervised the employees on training.
- Won outstanding performer of the month award multiple times.
- Received the Academic Excellence Award from the college upon completing Master of Pharmacy in Pharmacology.
Timeline
Senior Drug Safety Associate (Scientific Writing)
Accenture Operations
02.2021 - Current
Assistant Professor
KMP College of Pharmacy
04.2019 - 12.2020
Documentation Assistant (Part-Time)
Naerum Apotek
01.2017 - 11.2017
QC Analyst I (Medical Writing)
MMSH Clinical Research Pvt. Ltd
11.2015 - 11.2016
Pharmacist
Radha Medicals and Distributors Pvt. Ltd
02.2014 - 04.2015
Master of Pharmacy - Pharmacology
Shree Devi College Of Pharmacy, Mangalore
12.2011 - 12.2013
QC Analyst
Dyna Vetcare
09.2010 - 11.2011
Bachelor of Pharmacy - Pharmacy
Kalasalingam College of Pharmacy
09.2006 - 08.2010
Advanced Diploma in Clinical Research and Regulatory Writing - May 2015-Oct 2015 ICBio Clinical Research Pvt Ltd, Bangalore
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