Job Overview :

Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables

Ensure compliance of operations with governing regulatory requirements

Create, maintain and assume accountability for a culture of high customer service

Efficiency in conducting literature searches for authoring various types of reports

Write and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents, as assigned.

Perform / review Signal detection activities

Efficiency in conducting literature searches for authoring various types of reports

Write and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents, as assigned.

Perform / review Signal detection activities

Author / review RMPs, ad hoc reports, Safety Update reports, Benefit-Risk

Form SC-HR09B v0)

SC-HR09B Job Description Form Version 0, Dated 03-Nov-2014

Company Confidential Page 2 of 2

Evaluation, CCDS supporting document, ACOs, Addendum reports

Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.

Author / Review Investigator Brochures, Protocols, Informed Consent Forms (ICFs), and Case Report Forms (CRFs)

Author / review Clinical Study Reports for Ph 1-4 trials, including full study reports, abbreviated reports, web synopses, subject narratives

Author / review manuscripts, abstracts, posters for conferences

Prepare medical information responses for HCPs

Act as a writing coach, devise training programs

Author / review SOPs / WIs / process documents or sections as applicable

Impart / conduct Trainings for peers and team members

Coordinate activities related to various types of report writing across a team of writers if applicable

Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training

Assist in estimation of resource requirement and responding to RFPs as needed

Internal and external (client) communication & co-ordination to get the required inputs

Get resolution on issues affecting project deliverables

Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides

Search literature databases for relevant information, recommend label changes, author proposed label text and prepare supporting / justification document

Any additional activities as per the

Education / Qualifications :

Master’s degree in Pharmacy / related science area OR Bachelor’s degree in Medical

Experience :

HCP with 2-4 years of experience in Medical Writing / PV industry with experience in ophthalmology

At least 5 years’ experience in the pharmaceutical industry, with at least 3 years of it in

medical writing

Experience in Pharmacovigilance is desirable

Clinical Research, Good Clinical Practice

Strong working knowledge of anatomy, physiology, disease states, medical treatments

and procedures, medication names and drug therapy

Thorough understanding of drug safety

Orientation to pharmacokinetic and pharmacodynamic principles

Strong written and verbal language skills

Ability to analyze and synthesize medical information

Basic understanding of statistical concepts

Concern for quality, detail orientation

Coaching and mentoring