Medical Writing Specialist

2-4 years

Not Disclosed

Bangalore

15 June 12, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Department – Clinical Reporting Unit

Are you an experienced Medical Writing specialist with a strong background in regulatory medical writing? Do you have a passion for clear and concise communication of clinical data? We are looking for a Medical writing Specialist to join our Clinical Reporting team at Novo Nordisk. If you are ready for a new challenge and want to make a difference in the pharmaceutical industry, read on and apply today for a life-changing career.

About the department

The Clinical Reporting unit in Global Business Service has seen a tremendous growth curve and has become an integral part of the Global Clinical Reporting community in a short span of 6-7 years, since its inception in 2011. The team is a dynamic mix of enthusiastic and qualified skilled Medical Writers, Disclosure Medical Writers, Publishers, and Document Controllers with master/PhD in life sciences, pharmacology, medicine, etc. The team is full of commitment, passion, skills, and talent with broad knowledge of different therapeutic areas and regulatory requirements for submissions. The team has an average experience of 7-8 years in writing and reviewing regulatory documents and publications. We use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. Apart from writing and publishing regulatory documents, the team is also responsible for the distribution of documents (CONNECT portal) and largely contributes to NN’s regulatory commitments by being involved in public disclosure activities.

The position

As a Medical Writing Specialist, you will be responsible for performing medical writing tasks of high complexity and acting as a project manager. Your role will involve planning, developing, and overseeing regulatory documents across all phases of clinical development. This includes but is not limited to, the preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Meeting packages and briefing books, Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries, and Clinical overviews. In this role, you will be expected to set direction, drive discussions, ensure decisions are made, and influence and implement project strategy..

As a Medical Writing Specialist at Novo Nordisk, you will have the responsibilities to:

Communicate clinical data clearly and concisely, contributing to process improvements, knowledge sharing, and skill building. Mentor and train other medical writers as needed, while maintaining good relationships with stakeholders and colleagues.
Ensure timely, clear, and proactive communication and collaboration with stakeholders and colleagues globally. Assume the roles of Project Medical Writer (PMW) and Clinical Submission Team Lead (CST) for assigned projects.
Meet timelines by planning work effectively, being proactive when problems arise, and seeking help and advice from relevant individuals within GBS and HQ.
Support execution of Clinical Reporting strategy and vision in line with the leadership team. Challenge expert contributors on the clinical documents where the quality of their written contribution could be improved.
Ensure the accuracy and compliance of documents with regulatory standards and guidelines through expertise and attention to detail.

Qualification

You are expected to have the following skills and knowledge:

Graduate degree (PhD, MSc., M Pharm, or equivalent).
≥10+ years of experience as a medical writer or other relevant work experience.
Experience in regulatory medical writing, including Clinical Study Reports (CSR), protocols, Investigator Brochures (IB), informed consent forms, clinical summaries, and clinical overviews.
Excellent understanding of clinical development and regulatory processes and requirements.
Experience working in a global setting.
Experience in the pharmaceutical/CRO industry.
Strong understanding of external requirements related to regulatory documents.
Strong analytical skills, Excellent communication and presentation skills.
Committed, persistent, and accountable. Able to handle numerous tasks simultaneously.
Demonstrated ability to identify best practices and create improvements in methods, techniques, approaches, etc.
Proven track record of being a proactive team player and delivering on time and with high quality.

Working at NovoNordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life-changing.

Contact

To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).

Apply Now!

Deadline

30th June, 2024

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.