Sreelakshmi Konakanchi

Sreelakshmi Konakanchi Email and Phone Number

Regulatory Documentation Scientist @ Kateric
Sreelakshmi Konakanchi's Location
Bengaluru North, Karnataka, India, India
Sreelakshmi Konakanchi's Contact Details

Sreelakshmi Konakanchi personal email

About Sreelakshmi Konakanchi

Sreelakshmi Konakanchi is a Regulatory Documentation Scientist at Kateric. They possess expertise in medical writing, ich gcp, clinical trials, pharmacovigilance, oncology and 20 more skills. They is proficient in English, Telugu, and Hindi. Colleagues describe them as "Based on Sree’s accomplishments over the past 5 years and the professional growth she has exhibited, I would recommend Sree for an advanced writing position ( Medical Writer II and higher). During that time she has improved her communication skills and ability to work independently. Sree has learned to write several types of documents and willingly accepted the additional responsibilities associated with each of them. She takes ownership of her projects ensuring that quality documents… Show more" and "I've known Sreelakshmi as a Medical Writer, whose dedication and committment towards work reflected in the successful completion of an important project. Her meticulous approach towards attaining the goal is indeed appreciable. I wish her the best for all her future endevours. Thanks, Chandramouli Raju Senior MW"

Sreelakshmi Konakanchi's Current Company Details
Kateric

Kateric

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Regulatory Documentation Scientist
Sreelakshmi Konakanchi Work Experience Details
  • Kateric
    Regulatory Documentation Scientist
    Kateric Feb 2015 - Present
    Bengaluru Area, India
    Write and review Phase I-III CSRs, IBs, DSURs, PBRERs, CO, SCS, SCP, RMPs, and Briefing Packages in collaboration with Regulatory Project Managers, Clinical Science Leaders, and the International Project Team and in accordance with the Client Guidance Documents complying with the FDA/EMA regulatory guidelines.Authored and reviewed CTRs, protocols, and protocol annual updates submitted to ClinicalTrials.gov and European Clinical Trials Database (EudraCT). Experienced in handling the projects from kickoff to final submission to regulatory authorities.
  • Inventiv Health Clinical
    Senior Medical Writer
    Inventiv Health Clinical Nov 2011 - Jan 2015
    Hyderabad Area, India
    Performing Medical writing activities on the assigned projects in a timely and efficient manner.Responsible for quality check and content review of CSRs of all types and complexities for full (Phase 1-4), synoptic, noninterventional, methodology, consumer health care, supplemental, abbreviated CSRs, Basic Results documents, DSURs, PBRERs, RMPs, ISSs and ISEs in multiple therapeutic areas. Responsible for quality check and content review of publications like manuscripts, posters, abstracts, slide sets, oral presentations, regulatory responses, presentations for professional meetings/conferences in multiple therapeutic areas.Document retention lead and POC for document retention for the client. Oversight, monitoring, tracking, managing the end-to-end process, trouble shoot and fix the issues.
  • Cognizant Technology Solutions
    Analyst-Medical Writing
    Cognizant Technology Solutions May 2011 - Sep 2011
    Novartis, Hyderabad
    Involved in writing and reviewing for patient narratives project (Neuroscience). Did standard medical review against listings, patient profiles, clinical data base and safety data base. Managed the project in tight timelines and contributed to successful submission. Prepared study tracker tool for reconciliation and received recognition for project management.
  • Accenture Health Care
    Medical Writer/ Dq Specialist
    Accenture Health Care Mar 2007 - May 2008
    Reviewed CSRs of all types and complexities, IND ARs, Investigator's brochures, narratives, publication documents like manuscripts, abstracts, posters, regulatory responses, slide sets etc.
  • Meyer Health Care Pvt Ltd.
    Qc Executive
    Meyer Health Care Pvt Ltd. Jun 2004 - Jul 2005

Sreelakshmi Konakanchi Skills

Medical Writing Ich Gcp Clinical Trials Pharmacovigilance Oncology Gcp Regulatory Affairs Clinical Research Regulatory Submissions Pharmaceutical Industry Cro Clinical Data Management Clinical Development Edc Pharmacology Clinical Study Design Therapeutic Areas Neuroscience Sop Ctms Protocol Lifesciences 21 Cfr Part 11 Biotechnology Fda

Sreelakshmi Konakanchi Education Details

Frequently Asked Questions about Sreelakshmi Konakanchi

What company does Sreelakshmi Konakanchi work for?

Sreelakshmi Konakanchi works for Kateric

What is Sreelakshmi Konakanchi's role at the current company?

Sreelakshmi Konakanchi's current role is Regulatory Documentation Scientist.

What is Sreelakshmi Konakanchi's email address?

Sreelakshmi Konakanchi's email address is sr****@****ail.com

What schools did Sreelakshmi Konakanchi attend?

Sreelakshmi Konakanchi attended Institute Of Clinical Research, India, Jawaharlal Nehru Technological University, Adarsha Junior College.

What skills is Sreelakshmi Konakanchi known for?

Sreelakshmi Konakanchi has skills like Medical Writing, Ich Gcp, Clinical Trials, Pharmacovigilance, Oncology, Gcp, Regulatory Affairs, Clinical Research, Regulatory Submissions, Pharmaceutical Industry, Cro, Clinical Data Management.

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