Thermo Fisher Scientific Hiring for Sr Med Writer at Mumbai, India Full Time

PPD’s mission is to improve health.It starts as an idea to find a cure. It becomes a life saved. All in-between,it’s you! We know that meaningful results not only require the rightapproach, but also the right people. We invite you to re-imagine healthpromoting protocols with us, working alongside our talented, bright andenergetic teams.

We are passionate about being dataand technically agile and driving enhanced value for our clients and patients.Determined to improve patient health, we help PPD provide industry-leadingstatistical, programming and clinical pharmacology contributions through globaldelivery, consistent quality adherence and scientific insight.

As a SeniorMedical Writer, you will serve as the primary author by writing andproviding input on routine documents such as clinical study reports and studyprotocols and summarizes data from clinical studies.

At PPD we hire the best, developourselves and each other, and recognize the power of being one team. We offercontinued career advancement opportunities, award winning training and benefitsfocused on the health and well being of our employees.

Summarized Purpose:

Provides high-quality medical andscientific writing from planning and coordination through delivery of finaldrafts to internal and external clients. Demonstrates subject matter andtherapeutic area expertise. May assist program manager. Collaborates withinternal and external clients, supporting and enabling effective and efficientcommunication that results in operational excellence.

Essential Functions:

• Serves as primary authorwho writes and provides input on routine documents such as clinical studyreports and study protocols and summarizes data from clinicalstudies.

• Researches, writes,edits complex clinical and scientific and program level documents, includingIBs, INDs, and MAAs.

• Reviews routinedocuments prepared by junior team members. May provide training and mentorshipfor junior writers and program managers on document preparation, the use ofsoftware for document development, document types, regulatory requirements, andtherapeutic area knowledge.

• Ensures compliance withquality processes and requirements for assigned documents. Provides input onand independently develops best practices, methods and techniques for achievingoptimal results, including various client-specific processes.

• May assist in programmanagement activities. Identifies and resolves out-of-scope activities. Dutiescould include developing timelines, budgets, forecasts and contractmodifications.

• Represents thedepartment at project launch meetings, review meetings, and project teammeetings.

Education and Experience:

Bachelor’s degree in ascientific discipline or equivalent and relevant formal academic / vocationalqualification; Advanced degree preferred

Previous experience thatprovides the knowledge, skills, and abilities to perform the job (comparable to5+ years).

Experience working inthe pharmaceutical/CRO industry preferred

Additionalqualifications in medical writing (AMWA; EMWA; RAC) advantageous

In some cases, an equivalency,consisting of a combination of appropriate education, training and/or directlyrelated experience, will be considered enough for an individual to meet therequirements of the role.

Knowledge, Skills andAbilities:

• Excellent datainterpretation and medical writing skills, including grammatical, editorial,and proofreading skills

• Strong projectmanagement skills

• Excellent interpersonalskills including problem solving

• Strong negotiationskills

• Excellent oral andwritten communication skills with strong presentation skills

• Significant knowledge ofglobal, regional, national and other document development guidelines

• In-depth knowledge in aspecialty area such as preclinical, therapeutic, regulatory submissions,communications, etc.

• Great judgment anddecision-making skills

• Excellent computerskills and skilled with client templates; Good knowledge of document managementsystems and other relevant applications (e.g. Excel, Outlook)

Working Environment:

PPD values the health and well beingof our employees. We support and encourage individuals to create a healthy andbalanced environment where they can thrive.Below is listed the workingenvironment/requirements for this role:

Able to communicate, receive, andunderstand information and ideas with diverse groups of people in acomprehensible and reasonable manner.

Able to work upright and stationaryfor typical working hours.

Ability to use and learn standardoffice equipment and technology with proficiency.

Able to perform successfully underpressure while prioritizing and handling multiple projects oractivities.

May require travel. (Recruiterwill provide more details.)

PPD Defining Principles:

-We have a strong will to win – Weearn our customer’s trust -We are gamechangers – We do theright thing – We are one PPD –

If you resonate with our five principlesabove, and ultimately wish to accelerate the delivery of safe and effectivetherapeutics for some of the world’s most urgent health needs, then pleasesubmit your application – we’d love to hear from you.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.