Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: Senior Medical Writer/Associate Lead Medical Writer
Job Description
About the department
GD GSC was started in September 2007 and within a short span of six years since its inception, has transitioned from a small start-up to one of the largest units in GSC and a key contributor to Novo Nordisk clinical development portfolio.
As the organization is growing along with the R&D portfolio, we are looking for several new medical writing colleagues. Join us and you will work with dedicated specialists from around the world in a growing organisation. We offer unique opportunities for with a significant amount of individual responsibility and an important role in our evermore imperative work of bringing new and better treatments to the market.
In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure medical and scientific deliveries for clinical submissions and authorities while securing that the process lives up to uniform global standards, regulations and business ethics. We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society. You will join an international team of ~30 highly skilled medical writers and publishers who as a unit had a steep learning curve and took their first initial assignments within their first quarter of its inception in GDGSC Medical Writing Department. It has grown in strength and deliveries since then and contributes to a larger share of our portfolio. We are located at a state?of?the-art facility in the EPIP Area, Whitefield, Bangalore.
Main job tasks:
Perform medical writing tasks - including preparation of:
* Clinical trial reports (CTRs)
* Clinical trial results presentations for distribution to clinical investigators
* Investigator’s brochures (IBs)
* Clinical summary documents in CTD/eCTD format for regulatory submissions world-wide (including investigational medicinal product dossiers (IMPDs), investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs)
Perform publication planning tasks:
* Publications (abstracts, posters and slide presentations for conferences and other scientific meetings, and manuscripts for scientific journals)
* To liaise with the CMRs’ medical/marketing functions on local publication activities
* Other relevant ad-hoc documents
Contribution to knowledge sharing, skill building and good collaboration with stakeholders and colleagues:
- Participate in internal/external marketing/medical activities, e.g., expert meetings, lectures and conferences
- Contribute to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
- Contribute to process improvements
- Maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas
- Actively participate in relevant meetings, training sessions and seminars in the department, competency anchor and relevant project(s)
- Maintain a good working relationship with stakeholders and colleagues
Main stakeholders / reputation and results:
The work is complex and involves close collaboration with stakeholders world-wide with different professional and cultural backgrounds. Collaboration is required with people from the following functions: Medical, clinical pharmacology, biostatistics, trial management, regulatory, marketing, data management, health economics, epidemiology, biomodelling, pre-clinical and CMC. The majority of the relevant stakeholders are located in HQ.
- Trial managers, international medical officers, regulatory affairs, and marketing are dependent on the documents produced by medical writers, these documents include:
- CTRs and CTD clinical summary and overview documents - needed for the approval of labelling changes and new drugs
- IBs, and the clinical sections of IMPDs/INDs - key documents for initiating new trials
- Clinical trial results presentations for distribution to clinical investigators – contribution to the good working relationship with investigators
- Clinical trial report synopses, which for marketed products are posted on the “Clinical Trials at Novo Nordisk” portal and on “ClinicalTrial.gov” (web sites open to the general public) – and thus potentially impacting Novo Nordisk’s public reputation
- Conference abstracts and posters, and manuscripts for scientific journals - instrumental for marketing activities
Candidate Profile:
Education: Graduate (PhD, MSc, M.Pharm, MD, DDS, DVM or equivalent)
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Professional Experience
- ≥3 years of experience with scientific research methodology, including designing and conducting experiments, and analysing and reporting experimental results
- Experience with scientific writing in English (publications for peer reviewed journals or equivalent)
- Experience working within a global setting
- Strong understanding of external requirements related to regulatory documents
- Experience from the pharmaceutical /CRO industry
- Solid experience with drug application processes to FDA and EMEA
Additional Information:
Qualification: Graduate (PhD, MSc, M.Pharm, MD, DDS, DVM or equivalent)
Location: Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical writing
Post Date: 29th May, 2016
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