Lead Medical Writer

Position: Lead Medical Writer
Location: Chandigarh
Reports To: Head of Operations
Supervises: Senior Medical Writers and Medical Writers

Job Overview
Authoring and coordinating end-to-end process for preparation, review, approval and
distribution of clinical regulatory documents, including Protocols, Investigational New Drug (IND)
Application, Clinical Trial Application (CTA), Clinical Study Reports (CSRs), New Drug Application
(NDA) and Clinical Summaries associated with the assigned products in accordance with
worldwide regulatory requirements.
Provides basic-level oversight and guidance for the direct medical-writing support in the
production of clinical research documentation used in drug development and product
registrations

Functional Responsibilities
Responsible for any or all of the following activities:
• Leading the medical writing team for the design, planning, and preparation of high-quality
clinical documentation in support of clinical development, trials (e.g., pivotal CSRs), and
filings (e.g., clinical modules)
• Preparing regulatory clinical documents including Informed Consent Form (ICF),
Investigator’s Brochure (IB), Protocols, Protocol amendments, etc.
• Co-ordinating between multiple verticals/functions for effective collection of information
required for creation of Protocols and CSRs
• To independently manage and author high quality CSRs and its narratives, ICF, IB,
Protocols, Protocol amendments, CTD modules, etc.
• Contributing to planning and streamlining process for data analysis, interpretation and
presentation
• Ensuring presentation of analysed data in a clear, complete, accurate, and concise
demeanour
• Overseeing the work of other medical writers, providing scientific and operational
mentorship and coaching in the design, planning, and execution of their assignments.
• Preparation and self-reviewing of various disclosure documents including Protocol
Registration form, Results Registration form, Protocol amendments & updates, CSR
synopsis, etc.

Job Description

• Being aware of the current changes and developments undertaken by regulatory bodies
worldwide
• Building and implementing an effective plan for stakeholder and project management
• Ability to work independently with the delivery partners to ensure smooth and timely
delivery of documents/reports
• Maintain and enhance knowledge in the applicable areas based on project requirement
to ensure active participation in project planning and delivery.
Areas could be oncology,
diabetology, endocrinology, rheumatology, neurology, women's and men's health, etc.
• Demonstrate project management and time management skills
Note: The above statements describe the general nature and level of work to be performed and
are not an exhaustive list of all responsibilities required for the position.

Education
• M.
Pharm
• Postgraduation in Lifesciences or equivalent
• PhD.
is preferable

Skills and personal attributes
• Excellent communication and interpersonal skills.
• Fluency in spoken and written English
• Competence to build and effectively manage interpersonal relationships at all levels
with the project stakeholders
• Strong analytical skills
• Participates in strategy discussions, demonstrates ability to both differentiate and
determine optimal strategies
• In-depth knowledge of Clinical Medical Writing
• Excellent management skills
• Excellent active listening, negotiation and presentation skills
• Training Experience
• Attention to detail, setting high performance standards for quality
• Excellent time management skills with a proven ability to prioritize activities effectively
and to meet deadlines successfully
• Positive, go-getter attitude
• Ability to solve problems; multitasking
• Tackles complex problems; makes independent decisions using analysis to drive solutions
• Awareness of global culture

Job Description

• Computer proficiency: an ability to work with web-based applications, and proficiency in
the use of Windows Operating System and the MS Office suite (Word/Excel/ Power Point)

Minimum Work Experience
At least 6 years of experience in Regulatory Medical Writing.
Candidate must have exposure to
EU and US markets.

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