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Title:  Senior Medical Writer,R&D,Clinical Research

Requisition ID:  41748
Date:  Dec 5, 2021
Location: 

Bangalore, Karnataka, IN

Department:  R&D
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

 

The Applied Research & Technology Scouting (AR&TS) team within West is responsible for driving the future of the company by identifying and developing innovative products designed to improve patient lives.  The scope encompasses technology fields that are adjacent to and transformational to West’s core products.  This role will work within the recently established Clinical Research team to evaluate technologies and concepts with a focus on the clinical research domain. The team’s output will be a valuable addition to the new product development by creating a unique identity supported by evidence-based research.

 

The Sr.Medical Writer role with the AR&TS team is a scientifically driven role which requires scientific knowledge and writing skills for the communication of medical science information in scientific medical writing (covering medical studies and regulatory documents, or marketing medical writing). This role applies good  knowledge to understand and interpret hypothesis on observational human/animal studies. Suitable candidates will be expected to bring a depth of expertise, knowledge of current developments in both research and industry, and will make a significant contribution to the AR&TS Team and the future of West. 

  

Essential Duties and Responsibilities:

 
•Evaluate, analyze, and interpret the medical literature for preparing adequate study design, statistical significance, and scientific rigor.
•Responsible for Clinical Research studies including Preclinical Human and Animal model Studies
•Authors and edits clinical development document including, clinical protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, integrated safety and efficacy summaries, presentation material and publication to medical journals.
•Support the high quality medical and scientific writing by contributing as author to the protocol development, literature search study documents, data analysis/interpretation, and report writing.
•Achieves consistent high quality and full range for all the written deliverables in accordance with the objective and study end points.
•Manages Medical writing activities associated with individual studies, coordinating medical writing activities within and across department with minimal supervision.
•Authors medical/scientific communications or content related to clinical trial field.
•Independently researches, authors and edits study protocols, standard response documents as well as pre/post clinical study reports.
•Reviews pertinent literature, evaluating its applicability and incorporating the information into clinical documents.
•Responsible for presenting complex clinical and scientific documents such as posters, abstracts, presentation slide decks.
•Interacts and coordinates with internal and external stakeholders on significant matters involving functional and technical expertise.
•Monitors assigned projects and manage workload, taking ownership of the activities in addition to finding potential solutions to issues.
•Accountable for selecting methods and techniques for obtaining solutions that produce high quality results.
•Completes required administrated tasks within the specified timeframes.
•Other duties as assigned

 

Education and Experience: 
•An ideal candidate would hold a Master’s in scientific, medical, or clinical discipline.
•Experience:  5-8 years of experience, with working closely on the drafting and authoring of Clinical Study documents.
•Solid medical writing skills, including grammatical, editorial, and proofreading skills.
•High level of attention to details and superior English-language skills.
•Excellent written and verbal communication and ability to articulately disseminate scientific research to a variety of different audiences, from expert through to non-technical.
•Ability to understand and interpret statistical dataAnchor
•Strong understanding of ICH-GCP guidelines.
•Strong understanding and experience with diagnostic device /drug trials.
•Understanding the Clinical Study design and concepts with animal/ human study models.

 

Knowledge, Skills and Abilities:
•Experience with working in the pharmaceutical/CRO industry preferred.
•A Phd in life science will be a plus.
•Demonstrated ability to think Critically and Analytically
•Ability to work as part of a team as well as independently
•Familiarity with the use of statistical software, a plus.
•Aptitude for communicating scientific information in a succinct way
•Ability to work on medical literature and research data (via medical journals, and resources like Medline, PubMed, etc.)
•Capacity to understand and present complex clinical data
•Good knowledge of document management systems and relevant applications.

 

Physical and Travel Requirements

 •Occasional on-call work required
•Prefer 11 am – 8pm India time. Willingness to work outside of these hours as needed.

 

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West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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