Senior Medical Writer
Resume:
Cover letter
Please find attached my resume for your kind perusal.
I am confident of my knowledge, skills, and experience would prove beneficial to your
organisation. I would welcome an opportunity to discuss my qualifications with you in person.
Thank you for your attention and consideration.
Sincerely,
Sweta Bhattacharya
Sweta Bhattacharya
Current position
Senior Medical Writer, Quintiles Technologies India Pvt. Ltd., Bangalore
Mailing address
Flat number C1/701,
Alpine Eco Apartments,
Off Outer Ring Road,
Doddanakunde,
Marathahalli Post,
Bangalore – 560037
Mobile number
**********@*****.***
Summary
Professional medical writer with an experience of 8 years in clinical research with core medical
writing experience for more than 6 years.
I have been taking leading role in the preparation of or contributing to the production of most
types of clinical documents for partners and external customers for my current organisation. I
have also been acting as a mentor for other team members assisting in their training and
development.
I have been handling writing projects involving multiple writers/locations.
Looking forward for a long-term association with the esteemed organization of yours and to
learn and grow along with the organisation.
Objective
To develop a promising career (in management role) in the field of medical writing, clinical
research, health care, medical and life sciences (marketing), while being actively involved in the
development of the Company.
Skills and Abilities
• Situation-specific, excellent command over language and content of communication (both verbal
and written).
• In-depth knowledge of the structural and content requirements of regulatory documents, such as
Investigator’s Brochures, Study Design Concepts, Clinical Trial Protocols, Clinical Trial Reports,
narratives, Common Technical Document (CTD) summaries etc. and publication documents like
abstracts, posters, slide decks, manuscripts, etc.
• Ability to integrate, interpret and summarise data from a variety of sources in a clear and concise
manner.
• Good understanding of common statistical methods used in clinical trials and interpretation of
their results.
• Understanding of the time needed to perform tasks, agreeing to appropriate timelines and
providing accurate resource estimates and costing as per Company standards.
• Ability to give presentations to project teams and/or customers on project-specific topics.
• Providing effective and sensitive written and verbal feedback to other team members, when
appropriate.
• Effectively and proactively assessing and prioritizing work.
• Careful attention to detail and accuracy.
• Proficiency with all applications in Microsoft Office.
• Patience and good listening skill.
• Ability to see the "bigger picture" and promote this to team.
• Developing abilities to deal with personnel issues, team expectations, conflict management.
• Confidential and sensitive approach to earn trust of team.
• Effectively working as a team player contributing to team success.
Employment History
Quintiles Technologies India Pvt. Ltd.
Duration: August 2010 – Till date
Designation: Senior Medical Writer
Job responsibilities:
• Acting as Lead Medical Writer on most types of writing projects and taking responsibility for
preparation of assigned documents to a high standard, working in accordance with the Standard
Operating Practices (SOPs) and the customer's requirements.
• Participating in both internal and external project team meetings and liaising directly with
customers, as appropriate. Identifying project needs, negotiating and tracking project timelines
and implementing customer requests.
• Taking responsibility for planning and organizing workload for assigned projects and tasks and
offering proactive solutions and advice to customers as appropriate to experience.
• Reviewing and monitoring budget for assigned projects, including out-of-scope activities and
ensuring that revenue is recognised after project completion (with management support as
needed).
• Reviewing documents or parts of documents prepared by other team members (medical writers,
statisticians etc.) and providing appropriate feedback.
• Presenting on standard medical writing processes at full-service business development defence
meetings via telephone or in person.
• Contributing to Request for Proposals (RFPs), revisions of SOPs, preparation of training
documents and taking trainings for medical writing and other departments as per requirement.
• Working with senior management to understand and interpret Company strategies and effectively
communicating this to the team.
• Planning, assigning and directing work; setting goals and objectives, guiding professional
development; rewarding, addressing and resolving problems.
Achievements:
• “Work Worth Doing” awards received for multiple projects.
Cognizant Technology Solutions Pvt. Ltd.
Duration: December 2009 – July 2010
Designation: Senior Medical Writer
Job responsibilities:
• Performing Medical Writing activities on the assigned project in a timely and efficient manner.
• Supervision of pharmacovigilance projects, case processing involving ARGUS software.
• Content writing for e-learning modules for a US-based customer, instructional designing and
idea generation for graphic design.
• Generating queries to clarify and improve the quality of the data.
• Track metrics specified.
• Writing Clinical Study Reports and other regulatory submission documents.
• Performing Review and quality check of the deliverables.
• Providing trainings, contributing to re-structuring and re-modelling of RFPs and training
documents.
Achievement:
• Appreciations from US-based Customers for creation of e-learning modules in lesser times than
expected.
Accenture Services Private Ltd.
Duration: June 2005 – November 2009
Designation: Medical Writer/QC Reviewer (Level F)
Job responsibilities:
• Conducting kick off meeting with customers, which involved document definition meetings and
document interpretation meetings. Circulating the minutes of meeting (MOM) to the customers.
• With supervision, planning and preparing variety of clinical documents (eg. CTD modules,
Investigators Brochure, Clinical Study Reports, investigational new drug annual reports,
development safety update reports, periodic safety update reports, abridged CSRs, etc) by
organising, critically examining and interpreting scientific and statistical data. Document
assignments spanned a number of projects and/or therapeutic areas.
• Ensuring documents were of high quality, scientifically accurate, they met Company standards
and regulatory requirements (eg, SOPs and other required guidelines) and reflected a consensus
among team members that is acceptable to all appropriate reviewers.
• Ensuring documents are written clearly in appropriate grammar, syntax, medical terminology,
style and format as determined by Company guidance.
• Identifying and collating information, using a range of different methodologies, to meet project
objectives.
• Extracting relevant information from different data sources appropriate to project objectives.
• Addressing comments from Lead Writers, Medical Monitors and Clinical Scientists.
• Content review:
Supporting medical writers in terms of scientific and clinical aspects.
o
Ensuring that the medical writers follow all the regulatory guidelines.
o
Reviewing clinical data reports like adverse events, serious adverse events,
o
treatmentemergent adverse events, demographic and baseline characteristics,
discontinuations, laboratory data, electrocardiogram reports, etc.
Ensuring that the data and methods in all assigned documents agree with source
o
documents. Checking text, data and confirming incorporation of all protocol
amendments and errata.
Checking accuracy of appendices and other applicable documents.
o
Literature review of the medical/regulatory/Pharma documents.
o
Literature review using search engines like the internet and via telephone from the
o
mentor or subject matter expert located onshore.
Providing interpretation of findings and clarify with the onshore or offshore
o
writers/customers.
Comparing the results from multiple studies, within the context of their methods.
o
Cross-checking references and affiliations with valid sources.
o
Reviewing findings of the data check with the document authors if necessary.
o
Approaching to reference ordering, storage and management and maintaining a
o
‘knowledge store’ of journal and article access.
Editing all types of regulatory and publication documents using American
o
Medical Association (AMA) style of editing.
Correcting grammatical errors (subject/verb disagreement, incomplete sentences
o
and typographical errors, etc.).
Editing references per the journal or article style.
o
Assisting the team lead in coordinating activities like work load distribution,
o
validating reviews of junior level reviewers, tracking document of self and of the
team, responding customer mails and queries.
• Carrying out project management like time report, tracking sheet and metrics review activities.
• Conducting team meeting and noting down MOM and circulate to the customers.
• Conducting WebEx, teleconference or videoconference with customers when required.
• Being in the pilot batch, assisting in training of new hires, proactively design training modules
and mentoring the new hires.
• Additional responsibilities:
ISO security SPOC for the team ensuring that the team members were not
o
breaching any kind of company’s policies and guidelines.
SPOC for Business Continuity Plan ensuring that the business was not affected at
o
the time of a crisis. SPOC for Accenture trainings by identifying the training
needs of the employees and arrange necessary training programs for them;
technical as well as soft-skill developing courses.
Cross-training team members from different towers/departments.
o
Conducting regular process training based on the assessment scores.
o
Conducted regular skills assessment.
o
Conducting weekly WebEx and conference calls with customer to discuss quality
o
parameters and process changes.
Preparing/assisting with quality trackers for the team to facilitate quality work.
o
Conducting team-building activities at the workplace.
o
Achievements:
• “Numero Uno” award for the best performer as a business operator.
• “Culture Spot” award for the best people developer and value creator.
Formal Education History
Last Date Institution Education Completion
Area of Study
Attended Name, Country Level/Degree Status
Bangalore
06/2005 MSc Biotechnology Completed
University, India
Kolkata
07/2003 BSc Botany Hons Completed
University, India
International
United Business
MBA Healthcare and
Institute,
04/2013 (Healthcare and Hospital Started
Brussels,
Hospital Management
Belgium, India
Management)
Therapeutic Experience
• Women's Health/Sexual Health,
• Rheumatology,
• Psychiatry,
• Endocrinology,
• Dermatology,
• Oncology,
• Allergy/Immunology,
• Haematology/Oncology/Transplantation,
• Ophthalmology,
• Infectious Diseases,
• Cardiovascular Diseases, etc.
Document Types
• Investigator’s Brochures and updates to the same.
• Study Design Concept document/Concept Protocol.
• Protocol (Phases 1, 2, and 4).
• Informed consent forms.
• Clinical trial reports (Phases 1, 2, 3 and 4).
• Web synopses.
• Narratives.
• Common Technical Document modules such as clinical overviews and summaries, expert
reports, safety and efficacy summaries; Periodic Safety Update Reports (PSURs), bridging
reports, Annual Safety Reports (ASRs), etc.
• Publications – posters, abstracts, small manuscripts, slide decks, e-learning modules, education
materials.
Languages
• English,
• Bengali,
• Hindi, and
• Kannada.
References
Will surely be available upon request.
Declaration
I hereby declare that all the information furnished above is true to the best of my knowledge and
belief.
Place : Bangalore
Date : 28 April 2013 Sweta Bhattacharya
Contact this candidate